Senior Corporate Strategy Analyst

Director - Project Delivery

Customer Quality Engineer

Production Admin Support

Global Supply Chain Manager

Finance Manager

Core Operations Manager

Operator III, Packaging - 2nd Shift

Site Quality Leader

DEA Manager

Role Description: <ul><li>This role is part of the Strategy function for the Industrial Solutions Segment, will work on the most important strategic initiatives across the business and will report to strategy manager. </li><li>This position will be based in the city of Bangalore (India) and require 10-20% travel to client locations worldwide to meet colleagues, visit sites, and attend industry conferences. </li><li>India is an important business hub for client, with over 2,000 employees, including R&amp;D, Engineering, Strategy, and other functions.</li><li>This role is part of the Strategy function for the Industrial Solutions Segment, will work on the most important strategic initiatives across the business and will report to strategy manager. </li><li>This position will be based in the city of Bangalore (India) and require 10-20% travel to client locations worldwide to meet colleagues, visit sites, and attend industry conferences. India is an important business hub for client, with over 2,000 employees, including R&amp;D, Engineering, Strategy, and other functions.</li></ul> Responsibilities: <ul><li>In this critical role, the Strategy Analyst will support in developing strategies through key responsibilities in four major areas</li><li>Help to develop strategies that drive above-market organic and inorganic growth</li><li>Gather real-time input as the external environment evolves (e.g., technology, customer needs, regulations, competitors, etc.)</li><li>Help identify new growth platforms, growth opportunities through the identification of attractive market spaces, determining what it takes to win, assessing competitive position and business models, and then helping the organizing to align on the strategic direction and execution plan</li><li>Drive change – helping to implement projects to execute on strategic objectives</li></ul> Additional responsibilities include <ul><li>Collaborate with Corporate Strategy, and business units’ strategy teams to solve complex business problems</li><li>Translate business requests into well-defined problems</li><li>Develop strategies and approaches to fulfil complex project assignments in creative and meaningful ways</li><li>Perform market and competition analyses to generate impact driven insights at global and regional levels</li><li>Identify key trends across markets, industries, and competitors that affect our businesses</li><li>Create analytical models to address key business questions and translate outputs into clear findings and recommendations</li><li>Create compelling storylines to support leadership fact-based decision making</li><li>Support the successful development and deployment of the annual strategy development process</li><li>Track execution of the long-term strategy through a select set of strategy-to-execution KPIs, synthesize implications to the strategic plan and recommend potential course corrections</li></ul> Requirements: <ul><li>Bachelor’s degree, with strong quantitative skills</li><li>An MBA or a Masters degree are desirable but not required.</li><li>Experience in market research, quantitative analysis, management consulting or corporate strategy, as well are a plus</li><li>Experience creating presentations and communicating ideas and plans</li><li>Excellent proficiency in data analytics</li><li>Track record of demonstrated leadership potential through academic, work, and/or community activities</li><li>Strong sense of tact, confidentiality, and maturity</li></ul>

Responsibilities: <ul><li>Define, develop, and lead the company-wide project management strategy, ensuring all assigned project delivery activities support and advance the organizations strategic plan and business goals.</li><li>Lead as an ultimate escalation point for resource constraints, delivery challenges, and project risks, providing executive-level support to resolve critical issues and maintain delivery momentum.</li><li>Oversee and ensure rigorous management of project budgets, including monitoring actual costs versus budgets, approving financial reports, and driving cost optimization to safeguard financial performance.</li><li>Lead the governance of project change requests, ensuring timely communication of schedule and budget impacts. Drive proactive risk identification, assessment, and mitigation across all projects to minimize business disruption.</li><li>Provide oversight and strategic direction on contractor mitigation plans, procurement strategies, resource allocation, and acceleration programs to ensure projects meet agreed timelines and quality standards.</li><li>Collaborate closely with the Procurement and Contracts Department to ensure all necessary requirements are identified and addressed promptly, facilitating informed and efficient decision-making.</li><li>Cultivate and sustain strong relationships with internal and external stakeholders, including senior clients and commercial teams, enhancing collaboration and addressing escalations effectively.</li><li>Collaborate with sector heads, technical teams, and commercial functions to align project execution with broader organizational objectives, ensuring seamless integration and delivery of complex technical assignments</li><li>Champion the implementation of standardized, compliant project management processes and quality controls across all projects. Ensure adherence to statutory, regulatory, and company standards, including safety and engineering norms.</li><li>Guide the development and dissemination of critical project documentation, training materials, and user manuals to enable effective project handover and operational readiness.</li><li>Oversee the consolidation and analysis of project data and performance reports to inform executive decision-making and continuous improvement initiatives.</li><li>Establish clear roles, responsibilities, and authority levels across the project team, ensuring all members have a shared understanding of their accountabilities and reporting relationships to drive effective collaboration and execution.</li><li>Delegate tasks and decision-making authority appropriately across the team, promoting ownership and accountability while maintaining oversight to ensure alignment with project objectives and organizational standards.</li><li>Lead critical strategic initiatives by coordinating cross-functional teams and managing regulatory compliance and stakeholder engagement to ensure alignment with organizational goals.</li><li>Stay up to date with industry trends, emerging technologies, and global best practices in project management and real estate development. Apply relevant insights and develop opportunities to enhance delivery methods, ensure competitiveness, and drive innovation across projects.</li></ul> Requirements: <ul><li>Must have project delivery experience managing large-scale, complex developments, including 8+ years in a senior leadership role.&nbsp;</li><li>Bachelors or Masters degree in Civil Engineering, Architectural Engineering, or a related discipline.</li><li>Experience in managing the full project lifecycle - from initiation and planning through execution, monitoring, handover, and close- out.</li><li>Min of 15–20+ years experience, including 8+ years of experience in a senior leadership/project lead role - managing large-scale/ multi-disciplinary projects and teams. 5+ years of experience with a developer - preferable.</li><li>Understanding of industry-specific delivery standards and technologies, statutory, regulatory, and quality compliance requirements relevant to project delivery.</li><li>Familiar with UAE Building Codes, Environmental regulations, and Dubai construction laws</li></ul>

Responsibilities: <ul><li>Quality point of contact for Global strategic customer accounts.</li><li>Leads Quality / Reliability interactions with the customer, including regular communication and escalations.</li><li>Provide the Voice of the Customer feedback with product management, product engineering and manufacturing locations for characteristics that can become quality or application risks to the customer.</li><li>Provides internal and external technical support in evaluating products from a quality and reliability standpoint.</li><li>Leads cross-functional problem-solving teams to investigate quality issues and minimize customer impact, DPPM, cost of poor quality and drive timely resolution.</li><li>Influences without authority in efforts to achieve a robust 5D/8D response within agreed upon timeline.</li><li>Prepare comprehensive failure analysis reports that clearly communicate findings to both technical and non-technical stakeholders.</li><li>Drives systemic corrective action and continual improvement for customers through training and implementation and uses an array of quality improvement tools.</li><li>Regularly reports to management on the overall performance and effectiveness of the assigned global strategic customer account.</li><li>Manage quality issues or inquiries for parts in assigned Global Product Lines. The parts may be made at a company facility or at a sub-tier supplier.</li><li>Supports RMA team functions for disposition of non-conforming products.</li><li>Frequent OEM customer contract manufactures onsite investigations within Vietnam and Southeast Asia as needed to review company product, application use case, problem solve and provide solutions</li><li>Responsible for coordinating and ensuring completion of customer quality requested activities across design qualifications and manufacturing. This includes coordinating globally for all sites, factories, and associated teams within company.</li><li>Ensures compliance with company quality policies and procedures related to customer requirements.</li><li>Partners closely with sales, engineering, and operations to ensure organizational alignment regarding setting targets and achieving quality objectives for our customers.</li><li>Partners with engineering and sales to establish trust with our customers by sharing DDN strategic quality roadmap as well as resolving problems in a timely manner.</li><li>Acts as a liaison between company and the customer for Product Change Notifications and other contractual obligations.</li><li>Regularly conduct reviews with key customers regarding DDNs quality reliability performance.</li><li>Travel within Asia is required to work closely at customer onsite locations and other company locations, including overnight and multi-day trips.</li></ul> Requirements: <ul><li>Bachelor’s Degree with engineering technical focus.</li><li>Minimum 5+ years quality reliability and manufacturing experience working in a regional/global capacity.</li><li>Failure analysis expertise: plan, perform effective and efficient investigations using structured approaches such as fault trees to identify root cause and corrective actions.</li><li>Customer interface quality reliability experience in data center interconnect technology.</li><li>Demonstrated ability to lead teams, forge strong internal relationships, and drive improvement initiatives.</li><li>Knowledge and application of quality system regulations (ISO 9000, 14000 and 18000).</li><li>Experienced in the use Lean Six Sigma,8D methodology, Design of Experiments (DOE), Statistical Process Control (SPC), Process Capability (CpK) techniques, Gage R&amp;R and experience with application FMEAs.</li><li>Possesses strong leadership skills and executive level presence.</li><li>Self-motivated, efficient, ability to work with little or no supervision, and committed to a team approach.</li><li>Strong interpersonal, organization, and project management skills.</li><li>Ability to prioritize responsibilities in a fast-paced work environment.</li><li>Experience in core processes at component level including stamping, molding, plating, and next level assembly such as surface mount technology (SMT), press fit operations, system integrations and product testing.</li></ul>

Responsibilities: Attendance Management: <ul><li>Monitor and track employee attendance, clock-in/clock-out records, and shift schedules.</li><li>Review attendance data and investigate discrepancies, missed punches, and attendance exceptions.</li><li>Ensure attendance records are maintained accurately and updated in a timely manner.</li></ul> Leave Administration: <ul><li>Process and maintain employee leave records in accordance with company policies.</li><li>Coordinate with employees and supervisors to ensure proper documentation and approvals for leave applications.</li><li>Timesheet Verification &amp; Payroll Support</li><li>Verify timesheets for accuracy, completeness, and compliance with company requirements.</li><li>Support payroll processing by providing accurate attendance, overtime, and leave-related information.</li><li>Resolve timesheet discrepancies and coordinate with relevant stakeholders when necessary.</li></ul> Reporting &amp; Compliance: <ul><li>Generate regular reports on attendance, overtime, absenteeism, and workforce metrics.</li><li>Ensure compliance with attendance policies, labor regulations, and internal Standard Operating Procedures (SOPs).</li><li>Maintain accurate records and documentation for audit and operational requirements.</li><li>Administrative Support</li><li>Provide day-to-day administrative support to the operations team.</li><li>Assist with data entry, record maintenance, and workforce-related administrative activities.</li></ul> Requirements: <ul><li>Diploma, Certificate, SPM/STPM, or equivalent qualification.</li><li>Minimum 2-3 years of experience in administration, HR coordination, workforce administration, or operations support.</li><li>Able to work 12 hours shift (Day &amp; Night) for the Operations support.</li><li>Good proficiency in Microsoft Excel and other Microsoft Office applications.</li><li>Familiarity with Time &amp; Attendance Systems, HRIS, or workforce management systems.</li><li>Strong attention to detail and accuracy in handling employee records and data.</li><li>Good communication and interpersonal skills.</li><li>Strong organizational and time management skills.</li><li>Ability to multitask and work effectively in a fast-paced manufacturing or operational environment.</li><li>Good problem-solving skills and ability to handle confidential information professionally.</li></ul>

Responsibilities: <ul><li>Drive Ent to end Supply Chain role for assigned product portfolio across globe with manufacturing plants, subcontractors and suppliers.</li><li>Ensure the availability of Finish Goods and raw materials in the supply chain, as scheduled, and the maintenance of inventory at the established levels. </li><li>They coordinate and integrate the flow of materials and information among suppliers, manufacturers, distributors and customers, identifying opportunities for improving efficiency, effectiveness and capabilities of the supply chain. </li><li>Resources are focused on continuous improvement of the supply and service level as well as the stock healthiness, benchmarks to monitor actual performance against goals and definition of Root causes to drive improvement.</li><li>Actively participate in the Sales and Operations Planning (S&amp;OP) process providing the supply status, reviewing the demand outlook, and helping to create the S&amp;OP recommendations that is reviewed and approved by the Business, then drive execution of supply plan.</li><li>Help secure end to end alignment of the Signals – Guarantee effective communication upstreams of the Supply Plan / Built plan to follow from the factories and assess / identify constraints Mid Long run.</li><li>Propose and design Scenarios planning to help decisions making</li><li>Managing phase In / Phase Out process execution from a planning perspective on dedicated part of the portfolio</li><li>Manage End to end inventory performance and the identification of revenue risks and opportunities, supporting the decision-making process for potential trade-offs, including allocation of capacity.</li><li>Being a focal point to the Business/Category and market communication on status of supply, assurance of supplies, escalations, and allocation management working closely with Business Customer Care teams, Business Demand Planning Teams as well as the DC logistics teams.</li><li>Driving continuous improvement for owned key performance indicators such as Complete and On Time, Inventory, revenue realization, Order to Cash Lead time, Forecasting Accuracy Lead continuous improvement of trade compliance, Lead and coordinate cross-functional supply chain transformation projects from assessment through execution and stabilization.</li><li>Identify operational gaps, process inefficiencies, organizational constraints, and systemic risks across logistics and supply chain operations.</li><li>Drive structured problem-solving initiatives focused on service improvement, inventory optimization, logistics efficiency, and operational execution.</li><li>Establish Supply Chain governance standards, project tracking mechanisms, escalation processes, and executive reporting cadence.</li><li>Monitor KPIs and operational performance indicators to identify trends, gaps, and improvement opportunities.</li><li>Lead workshops, Kaizen events, operational reviews, and transformation discussions with cross-functional stakeholders.</li><li>Ensure accountability and follow-through on action items, project deliverables, and implementation milestones.</li><li>Drive change management initiatives to support adoption of new processes, organizational structures, and operational standards.</li><li>Provide executive-level visibility through structured reporting, performance summaries, and leadership presentations.</li><li>Promote standardization, scalability, and continuous improvement across regional and global supply chain operations.</li></ul> General <ul><li>Data Analysis: Conduct thorough data analysis to identify trends, patterns, and opportunities for improvement.</li><li>Stakeholder Collaboration: Work closely with cross-functional teams, including procurement, operations, and finance, to achieve project goals.</li><li>Reporting and Documentation: Prepare regular reports and documentation to track progress and communicate results to senior management.</li><li>Ensure process adherence and follow - up with ground team to provide an unparalleled delivery experience to customers/ cross functional teams</li></ul> Requirements: <ul><li>Bachelor or master’s degree in Supply Chain, Logistics, Business Administration or related field from a Tier-1 college.</li></ul> Professional Experience&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<ul><li>Strong knowledge of US Export Control &amp; CN IM/EX laws and regulations.</li><li>10+ years in supply chain/material planning within manufacturing or OEM</li><li>Minimum 3+ years in a leader role</li><li>Strong skills in planning, forecasting, inventory control, and data analysis</li><li>Proven leadership, stakeholder management, and problem-solving abilities</li><li>Experience working in a fast-paced, global environment</li><li>Good English communication (verbal and written).</li><li>High level understanding of supply chain concepts- Network, Transportation, Warehousing &amp; Inventory etc.</li><li>Prior working knowledge in Analytics using Analytic tools is a Must</li><li>Must have- Excellent MS PowerPoint and Excel skills</li><li>Preferable- Power Bi, Tableau, SAP, SQL</li><li>APICS, Lean certification, IBF or equivalent certification is a plus</li></ul> Special Qualifications, Knowledge &amp; Skills <ul><li>Ability to perform multiple tasks, adjust quickly in short time frame with limited direct supervision.</li><li>Ability to create rapport with others and build a team environment</li><li>Ability to work flexible hours if necessary</li><li>Can apply first principles thinking to solve problems, Self-motivated and bias for action/ ownership</li><li>Strong written and verbal communication , organizational , motivational and time management skills</li><li>Excellent Facilitation skills</li><li>Want to work with some really smart people , and still raise the bar for all of us</li></ul>

Responsibilities: Financial Planning &amp; Analysis (FP&amp;A): <ul><li>Lead the annual budgeting, forecasting, and long-term financial planning processes;</li><li>Prepare monthly, quarterly, and annual financial forecasts and variance analyses;</li><li>Provide insights and recommendations to senior management to support strategic decision-making;</li><li>Analyse business performance, trends, and key drivers (revenue, costs, margins, cash flow);</li><li>Partner with business leaders to improve financial performance and cost efficiency;</li></ul> Financial Control &amp; Reporting: <ul><li>Ensure accurate and timely month-end, quarter-end, and year-end close processes; Approve monthly Financial Statements in US GAAP ;</li><li>Prepare statutory financial statements in accordance with Danish GAAP and IFRS (if applicable) for Statutory Financial Audit ( each year around November);</li><li>Maintain the general ledger and ensure proper accounting treatment of transactions;</li><li>Oversee and approve reconciliations (balance sheet, bank, intercompany accounts, etc.);</li><li>Ensure compliance with internal controls and company policies;</li><li>Maintain documentation and audit trails for all financial activities;Tax &amp; Compliance (SKAT):</li><li>Ensure compliance with Danish tax regulations (corporate tax, VAT, payroll taxes);</li><li>Review VAT returns and other required filings with SKAT (Danish Tax Agency);</li><li>Coordinate corporate income tax reporting with external advisors;</li><li>Monitor changes in Danish tax legislation and assess business impact;</li><li>Ensure compliance with transfer pricing requirements and documentation;</li><li>Manage communication and correspondence with SKAT authorities;</li></ul> Audit &amp; External Reporting: <ul><li>Act as primary contact for external auditors and manage the annual audit process;</li><li>Coordinate audit schedules and prepare where needed, documentation, and responses to audit queries;</li><li>Ensure timely resolution of audit findings and implementation of recommendations;</li><li>Coordinate with internal audit (if applicable/ needed);</li><li>Ensure statutory filings are completed with Danish authorities (e.g., Danish Business Authority – Erhvervsstyrelsen) ( usual deadline is 30th of March for prior Fiscal year)</li></ul> Administrative &amp; Regulatory Responsibilities: <ul><li>Manage company digital mail system (e-Boks) and ensure timely handling of official correspondence as well as related business partners ( invoices to be forwarded to responsible AP partner, compliance requests, etc);</li><li>Oversee compliance with local statutory requirements and filings;</li><li>Maintain relationships with banks, tax advisors, and regulatory authorities;</li><li>Ensure proper corporate governance documentation and filings;</li></ul> Cash Flow &amp; Treasury Management: <ul><li>Monitor and manage cash flow, liquidity, and working capital;</li><li>Optimize cash management processes and approve forecasting;</li><li>Oversee banking relationships and approvals;</li><li>Manage intercompany funding and vendor related payments;</li></ul> Team Leadership &amp; Stakeholder Management: <ul><li>Lead and develop the local finance team (if applicable);</li><li>Collaborate with global finance and regional teams;</li><li>Act as a strategic business partner to local leadership;</li></ul> Requirements: <ul><li>Bachelor’s or Master’s degree in Finance, Accounting, or related field;</li><li>5–10+ years of experience in FP&amp;A, Financial Controlling, or similar roles;</li><li>Experience managing audits and financial reporting;</li><li>Advanced Excel and financial modelling skills;</li><li>Experience with ERP systems (Oracle, IndustriOS).</li></ul> Preferred qualifications and experience: <ul><li>Experience with Danish accounting standards and tax regulations is a plus.</li><li>Professional qualification (e.g., ACCA, CPA, CMA, or equivalent) preferred;</li></ul>

Responsibilities: <ul><li>Core Network Operations: Manage and monitor the day-to-day operations of the core network elements, including MSC (Mobile Switching Center), GGSN/SGSN, EPC (Evolved Packet Core), and IMS (IP Multimedia Subsystem), to ensure high availability and quality of service.</li><li>Performance Optimization: Regularly assess and optimize network performance. Work with network engineers to analyze key performance indicators (KPIs) and implement improvements to enhance network reliability and efficiency.</li><li>Troubleshooting &amp; Incident Management: Lead the troubleshooting of core network issues, coordinating with technical teams to resolve incidents quickly and minimize service disruption.</li><li>Capacity Planning: Monitor and analyze traffic patterns to ensure that core network capacity meets current and projected demands.&nbsp;</li><li>Propose and implement capacity expansion plans as needed.</li><li>Vendor Coordination: Coordinate with external vendors for the maintenance, upgrades, and support of core network equipment.&nbsp;</li><li>Ensure that vendor service level agreements (SLAs) are met and that any issues are escalated and resolved efficiently.</li><li>Project Implementation: Support the implementation of network projects, including network upgrades, technology rollouts (e.g., 4G/5G), and new service introductions. Collaborate with project managers and other stakeholders to ensure successful project delivery.</li><li>Network Security &amp; Compliance: Ensure compliance with security protocols and regulatory standards, safeguarding the core network against cyber threats and maintaining data integrity.</li><li>Reporting &amp; Documentation: Maintain accurate documentation of core network architecture, configurations, and changes. Prepare regular reports on network performance, incidents, and capacity planning.</li><li>Continuous Improvement: Identify and recommend new technologies, tools, and practices to enhance core network operations and stay current with industry standards.</li></ul> Requirements: <ul><li>Bachelor’s degree in Telecommunications, Electrical Engineering, Computer Science, or a related field.</li><li>Professional certifications such as CCNA, CCNP, or certifications specific to mobile core network technologies.</li><li>8+ years of experience in telecommunications, with a focus on core network management in a mobile operator setting.</li><li>Proven experience with troubleshooting and incident resolution within mobile core networks.</li><li>Experience with 5G core network components and technologies.</li><li>Project management experience or certifications (e.g., PMP, …).</li><li>In-depth knowledge of core network architecture and protocols, including GSM, UMTS, LTE, IMS, and EPC.</li><li>Strong understanding of core network protocols such as SIP, Diameter, GTP, and IP routing.</li><li>Familiarity with network monitoring and management tools.</li><li>Knowledge of network security and compliance regulations.</li><li>Good communication and teamwork skills, with the ability to work across multiple teams and coordinate with vendors.</li><li>Strong organizational and project management skills, with the ability to prioritize tasks effectively.</li><li>Strong analytical and problem-solving skills for rapid issue resolutions.</li><li>Attention to detail with a proactive approach to identifying and addressing network issues.</li><li>Ability to work well in a fast-paced, dynamic environment.</li><li>Strong sense of responsibility and commitment to service quality.</li></ul>

Role Description: <ul><li>With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. </li><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department. </li><li>Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.</li></ul> Responsibilities: Packaging Operations: <ul><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department</li><li>Is qualified in both Filling and Labeling</li><li>Ensures that all equipment is running properly</li><li>Executes processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.</li><li>May request components, labels and inserts per the BPR</li><li>Sets up packaging machinery; accurately sets equipment programming according to BPRs and SOPs</li><li>Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines</li><li>Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy</li><li>Accurately reviews BPRs steps for completeness and accuracy</li><li>Collects samples from each batch and submits to QA for retained samples</li><li>Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner</li></ul> Equipment Cleaning: <ul><li>Conducts verification of line/equipment cleaning and documents per SOP</li><li>Executes the procedures used to clean pharmaceutical packaging equipment and facilities</li><li>Conducts Master Cleans and Surface Cleans</li></ul> Continuous Improvement : <ul><li>Identifies 6S opportunities and sustains the 6S process</li><li>Assists in troubleshooting process issues</li></ul> Issues and Deviations: <ul><li>Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.</li></ul> Quality: <ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul> Teamwork and Collaboration: <ul><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li></ul> Training: <ul><li>Stays current on SOPs and cGMPs.</li><li>May participate in training qualifier classes.</li></ul> Safety and Compliance: <ul><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies</li></ul> Misc.: <ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent.</li><li>3 years of packaging experience</li></ul> Knowledge &amp; Skills: <ul><li>Knowledge of cGMP regulations and processes.</li><li>Qualified in both Filling and Labeling</li><li>Qualified and capable of setting up and running all machinery in the value stream</li><li>Competent in Master Clean/Surface Clean</li><li>Ability to sample batches</li><li>Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation</li><li>Ability to accurately and precisely record data and batch information</li><li>Ability to work in both independent and team environments</li><li>May become a certified trainer and provide certified training in one process</li><li>Effectively interfaces with other department personnel if Senior level (4th level) isn’t available</li><li>Ability to troubleshoot process issues</li><li>Ability to Identify 6S opportunities and sustain the 6S process</li><li>Ability to participate in Continuous Improvement projects</li><li>Proficient in reading and writing English to understand work instructions and document results</li></ul> Physical Requirements: <ul><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</li></ul>

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40 regulations Jobs found

Senior Corporate Strategy Analyst

Director - Project Delivery

Customer Quality Engineer

Production Admin Support

Global Supply Chain Manager

Finance Manager

Core Operations Manager

Operator III, Packaging - 2nd Shift

Site Quality Leader

DEA Manager

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40 regulations Jobs found

Senior Corporate Strategy Analyst

Director - Project Delivery

Customer Quality Engineer

Production Admin Support

Global Supply Chain Manager

Finance Manager

Core Operations Manager

Operator III, Packaging - 2nd Shift

Site Quality Leader

DEA Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.