Finance Manager

Financial Reporting and Accounting Lead

Regulatory Affairs Representative I

Associate Director– Business Transformation Food & Agri Industry

Core Operations Manager

Operator III, Packaging - 2nd Shift

Site Quality Leader

EHS Analyst

Manager, Production & CI

DEA Manager

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>Supervise the general accounting of the business unit, providing leadership, mentorship to colleagues, and fostering a collaborative work environment to drive performance and professional development.</li><li>Oversee daily financial data entry in the ERP system, ensuring accuracy and completeness.&nbsp;</li><li>Prepare and post journal entries and manage general ledger account reconciliations to maintain financial integrity.</li><li>Lead the monthly, quarterly, and annual closing processes, ensuring all financial activities are accurately captured. Prepare detailed financial data for management review and facilitate necessary adjustments.</li><li>Analyze balance sheet and income statement accounts, providing insightful variance analysis and reports that deliver actionable insights for informed decision-making.</li><li>Review and present financial reports to ensure compliance with accounting standards and local regulations. Collaborate with cross-functional teams to integrate financial data and streamline reporting processes.</li><li>Contribute to the development and implementation of policies and procedures for the general accounting function, ensuring alignment with the company’s financial goals and risk management strategies.</li><li>Develop ad-hoc reports and support special projects, such as financial data analysis and process improvements.</li><li>Lead the annual budgeting of SGA and COS departments costs and help providing insightful data for an accurate forecast.</li><li>Provide support on Annual Statutory Audit of the financial statements, as well as support for tax and transfer price documentation.</li></ul> Requirements: <ul><li>Bachelor’s degree in finance, accounting, Business Administration or a related field</li><li>4 - 7 years of relevant experience with general accounting.</li><li>Strong analytical skills with the ability to interpret financial data and generate reports.</li><li>Excellent attention to detail and ability to work under tight deadlines</li><li>Proficiency with Microsoft Office Suite</li><li>Familiarity with financial software and Oracle, Hyperion</li><li>Solid regional accounting knowledge (i.e., US GAAP and IFRS)</li><li>Fluency in English both spoken and written, is required.</li><li>Preferred qualifications and experience:</li><li>Master’s degree in a relevant field or Chartered Accountant designation</li></ul>

Responsibilities:&nbsp;&nbsp; <ul><li>Assists in the planning, development, maintenance, and implementation of the SDS authoring process.</li><li>Partners across all areas of expertise within the PSRA organization to monitor, promote, and deliver high quality, and fully compliant SDSs.</li><li>Identifies key measures to assist in driving continuous improvements and adherence to applicable regulatory requirements.</li><li>Actively fosters an organizational culture that is based on collaboration, partnership, innovation, customer service, driving change, and teamwork.</li><li>SDS and label data maintenance for new and existing products, intermediates and experimental products. Position works under direct supervision as needed.</li><li>Maintain regulatory and compositional information from raw materials suppliers and our businesses.</li><li>Manage our translation process with a 3rd party vendor.</li><li>Enter and maintain hazard assessment and regulatory data into product compliance support and MSDS authoring systems.</li><li>Provide internal and external customer support related to hazard communication including SDS distribution.</li><li>Actively participate in projects to continue to maintain compliance with global hazard communication regulations and related regulatory requirements.</li><li>Use product compliance tools to retrieve/query production models, specifications, recipes, labeling information, global database searches.</li><li>Support Product Stewardship and Regulatory Affairs activities.</li><li>Assist in special assignments and accepting new responsibilities as needed. External Use</li><li>Contribute to group projects by offering proposed solutions to problems and methods to accomplish the goals of the Product Stewardship and Regulatory Affairs Group.</li></ul> Requirements: Basic Qualifications:&nbsp; <ul><li>Associate degree in chemistry, Biological Sciences, Toxicology or HSE related field or equivalent experience in these fields.</li><li>Zero to two years of relevant experience.</li><li>Knowledge of MS excel, spreadsheet software, SAP like tools or similar Applications.</li></ul> Preferred Qualifications:&nbsp; <ul><li>Ability to multi-task and adapt to changing work priorities in a dynamic environment.</li><li>Strong interpersonal skills required to facilitate team building and partnering with colleagues and peers.</li><li>Ability to focus on details, work autonomously and lead projects.</li><li>SAP EHS module experience a plus.</li><li>Results driven with excellent communication skills.</li><li>Ability to handle multiple tasks/priorities and deal with ambiguity to meet specified deadlines.</li><li>Good analytical, problem solving and organizational skills.</li><li>Self-motivated, detail-oriented and comfortable working in a team environment.</li><li>Experience with innovative methodology for capturing and identifying metrics of key performance indicators.&nbsp;&nbsp;</li></ul>

Role Description: <ul><li>The Associate Director of Business Transformation (BT) for Food and Agriculture (F&amp;A) Industry will play an important role in building and growing our consulting services within the Food &amp; Agri vertical.</li><li>This role requires strong domain expertise, superior consulting skills, and a proven track record.&nbsp;</li></ul> Responsibilities: Leadership and Strategy <ul><li>Grow and expand the Business Transformation Solutions practice for Food &amp; Agri domain.&nbsp;</li><li>This includes refining and executing a strategy/GTM POV.</li><li>Lead and mentor the junior consultants within the team.</li><li>Foster a culture of innovation, collaboration, and continuous improvement within the business transformation team.</li><li>Identify and assess emerging trends and technologies to drive service offerings and client solutions.</li></ul> Client Engagement and Business Development <ul><li>Develop strong relationships with key stakeholders in the Food &amp; Agri domain.</li><li>Lead business development efforts, including identifying and pursuing new business opportunities, proposal development (along with pre-sales team), and client presentations.</li><li>Collaborate with sales and marketing teams to develop and implement go-to-market strategies for Business Transformation services.</li><li>Ensure a high level of client satisfaction through a strong understanding of the F&amp;A industry and focus on value creation &amp; ROI for clients.</li></ul> Project Management and Delivery <ul><li>Lead the execution, and successful delivery, of business transformation projects, ensuring they are completed on time, within scope, and within budget.</li><li>Take accountability for project governance and best practices to ensure consistent project execution and quality.</li><li>Provide guidance and support to junior members within the BTS team, as well as any other practice members participating in the project, helping them navigate operational challenges and deliver impactful results.</li></ul> Market Insights &amp; Trends:&nbsp; <ul><li>Stay informed about industry trends, competitive landscape, and regulatory changes impacting healthcare and life sciences to inform strategic decision-making.</li><li>Contribute to thought leadership initiatives, positioning the company as a trusted advisor in the industry.</li></ul> Requirements: <ul><li>Around 10 years of experience with minimum 5 years in consulting/technology consulting.</li><li>Proven track record of growing a business transformation/consulting practice.</li><li>Strong Food &amp; Agri domain expertise, with a solid understanding of industry challenges, trends, and regulations.</li><li>Experience with a variety of technology solutions relevant for Food &amp; Agri domain.</li></ul> Skills, Other requirements <ul><li>Superior leadership and team management skills.</li><li>High drive and energy to plan and execute consulting projects for our client.</li><li>Strong business acumen and strategic thinking abilities, with a focus on driving results and achieving business objectives.</li><li>Excellent communication and interpersonal skills, with the ability to build and maintain relationships with clients, stakeholders, and team members.</li><li>Strong problem-solving and analytical skills, with a focus on delivering innovative and practical solutions.</li><li>Proven track record in US and/or Asian markets and Food &amp; Agri clients.</li><li>Role will involve significant travel.</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>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Responsibilities:&nbsp; <ul><li>Train and develop team members to foster a culture of continuous improvement and operational excellence.</li><li>Be accountable of site production teams’ engagement.</li><li>Follow up site production team capabilities and create a multi functional environment.</li><li>Lead and coordinate daily production activities to meet production targets, quality standards, and delivery deadlines.</li><li>Develop and implement process improvements using continuous improvement methodologies.</li><li>Analyze production data to identify areas for efficiency gains and waste reduction.</li><li>Collaborate with cross-functional teams (engineering, quality, supply chain) to resolve production issues.</li><li>Monitor key performance indicators (KPIs) related to production efficiency, waste, safety, and quality.</li><li>Ensure compliance with safety regulations and promote a safe working environment.</li><li>Manage resources effectively, including workforce planning and equipment utilization.</li><li>Prepare reports on production.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering</li><li>Minimum 10 years of experience in production management, continuous improvement, or operational efficiency roles.</li><li>Strong expertise in Lean Manufacturing, TPM, WCM, IWS or other process improvement methodologies</li><li>Excellent analytical and problem-solving skills, with proficiency in data-driven decision-making.</li><li>Experience in the tobacco or FMCG industry is highly desirable.</li><li>Strong leadership abilities to drive change and influence teams across different levels of the organization.</li><li>Ability to manage multiple projects efficiently in a fast-paced environment.</li><li>Additional support activities as assigned.</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

Finance Manager

Financial Reporting and Accounting Lead

Regulatory Affairs Representative I

Associate Director– Business Transformation Food & Agri Industry

Core Operations Manager

Operator III, Packaging - 2nd Shift

Site Quality Leader

EHS Analyst

Manager, Production & CI

DEA Manager

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40 regulations Jobs found

Finance Manager

Financial Reporting and Accounting Lead

Regulatory Affairs Representative I

Associate Director– Business Transformation Food & Agri Industry

Core Operations Manager

Operator III, Packaging - 2nd Shift

Site Quality Leader

EHS Analyst

Manager, Production & CI

DEA Manager

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