Customer Service Specialist

Operator III, Packaging - 2nd Shift

Business Process Analyst – Purchasing

Business Process Analyst – Warehouse/Logistics

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Sales Manager (Cold Chain)

Strategic Sourcing III – Indirect Procurement

Process Engineering Manager

Site Quality Leader

Responsibilities: Quote and Order Management: <ul><li>Interface with Customers for Quote request or Price inquiries and approval</li><li>Submit quotation request for pricing team approval.&nbsp;</li><li>Sales order entry, order confirmation &amp; expediting orders.</li><li>Order change and backlog price adjustment</li><li>On-going Backlog Management</li><li>Shipment release and follow up</li><li>Report and support past due backlog reduction</li><li>NPI - follow up with PM/Plant/Finance for part master and cost setup</li><li>Handle Sample order</li><li>Process RMA / Goods replacement</li></ul> Customer Service: <ul><li>Handle customer enquiries &amp; complaints. Investigate and work with other departments to resolve customer issues in a timely manner.&nbsp;</li><li>Emails/Conference calls / Customer and company Plant Visits for critical delivery issues, expedition or projects.&nbsp;</li><li>Work out solutions on Customer’s special requirements, such as label, Customs process, packing &amp; etc.&nbsp;</li><li>NPS/VOC/Customer Service Survey Improvement Process. Identify and work on corrective actions to recurring issues.&nbsp;</li></ul> Customer Supply Chain Management: <ul><li>Initiate Stock Requisition for customer advance order or buffer stock.</li><li>Work with Planning team on capacity adjustment in order to fulfill Customer’s demands</li><li>Consignment Stock Management/ Customer demand forecast monitoring and accuracy analysis</li><li>Manage customer forecast/demand and inventory level, work with Supply Chain to fulfill customer demand.&nbsp;</li><li>Negotiate with Customer for VMI liability and deadstock compensation.</li><li>Resolve logistics and custom issues with relevant functions</li></ul> Customer Credit and Billing Management: <ul><li>Billing attainment</li><li>Follow up queries with Account Receivable</li><li>Coordinate with Finance and Customer to solve pass due invoices issue</li><li>Manage customer credit status &amp; escalate for any abnormal status</li><li>Apply credit release</li><li>Process Credit note / Debit Note</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent</li><li>2–3+ years in customer service / order management (manufacturing preferred)</li><li>Strong communication and stakeholder management skills</li><li>Experience handling customer complaints and resolution</li><li>Ability to work under pressure in a fast-paced environment</li><li>Proactive mindset with strong ownership and accountability</li><li>SAP knowledge preferred</li><li>Mandarin communication capability is a plus</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>

Responsibilities: Process Documentation and Modelling: <ul><li>Collaborate with business stakeholders and process owners to understand and document existing processes using BPMN notation.</li><li>Create detailed process maps, workflows, and diagrams that accurately represent the end-to-end processes and related activities (process map should include clear RACI, Tools, WI)</li><li>Ensure that all process documentation is clear, consistent, and follows best practices in BPMN modelling.</li><li>Adopt Single Source of Truth concept, utilize BPMN-tool to create, update, and maintain process documentation in a centralized and accessible manner.</li><li>Ensure process KPI are define &amp; documented</li></ul> Process Analysis and Optimization: <ul><li>Work with process owner to analyse processes &amp; identify inefficiencies, bottlenecks, and areas for improvement.</li><li>Work with process owner &amp; cross-functional teams to propose for process optimizations and enhancements using BPMN-tool capabilities.</li><li>Validate process changes with stakeholders and ensure that process improvements align with organizational goals, including handshake process to cross functional team</li><li>Ability to perform data analysis with big data and summarize into actionable insight</li></ul> System Knowledge &amp; Analysis: <ul><li>Understand D365 system logic &amp; guide users to follow the documented purchasing processes &amp; principles during day-to-day operation</li><li>Able to drill through system data &amp; perform analysis per business request using available analytic tools (PowerBI, Excel, Power Apps, etc)&nbsp;</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Management, Purchasing or a related field. Masters degree is a plus.</li><li>Proven experience (typically 5+ years) in business process management, process documentation, or related roles.</li><li>At least 3 years working experience in operational supply chain functions (mainly focus on purchasing)</li><li>Excellent project management skills, planning, prioritization, ability to innovate and execute on solutions that matter, and provide timely updates/recommendations.</li><li>Good analytical, influencing and problem-solving skills and ability to handle team and client discussions.</li><li>Flexible to take on ad-hoc assignment or project as necessary.</li><li>Logical &amp; Analytical mindset with the ability to identify process improvement opportunities through data analysis.</li><li>Excellent communication skills, both written and verbal, to effectively collaborate with stakeholders and present complex concepts.</li><li>Understanding of process improvement methodologies such as Lean, Six Sigma, or Business Process Reengineering (BPR).</li><li>Familiarity with compliance and regulatory requirements related to business processes.</li><li>Experience with stakeholder management with strong influencing skillset</li></ul>

Responsibilities: Process Documentation and Modelling: <ul><li>Collaborate with business stakeholders and process owners to understand and document existing processes using BPMN notation.</li><li>Create detailed process maps, workflows, and diagrams that accurately represent the end-to-end processes and related activities (process map should include clear RACI, Tools, WI)</li><li>Ensure that all process documentation is clear, consistent, and follows best practices in BPMN modelling.</li><li>Adopt Single Source of Truth concept, utilize BPMN-tool to create, update, and maintain process documentation in a centralized and accessible manner.</li><li>Ensure process KPI are documented</li></ul> Process Analysis and Optimization: <ul><li>Work with process owner to analyse processes &amp; identify inefficiencies, bottlenecks, and areas for improvement.</li><li>Work with process owner &amp; cross-functional teams to propose for process optimizations and enhancements using BPMN-tool capabilities.</li><li>Validate process changes with stakeholders and ensure that process improvements align with organizational goals, including handshake process to cross functional team</li></ul> System Knowledge &amp; Analysis: <ul><li>Understand D365 system logic &amp; guide users to follow the documented planning processes &amp; principles during day-to-day operation</li><li>Able to drill through system data &amp; perform analysis per business request using available analytic tools</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Management, Information Technology, Warehouse/Logistic or a related field. Masters degree is a plus.</li><li>Proven experience (typically 5+ years) in business process management, process documentation, or related roles.</li><li>At least 3 years working experience in operational supply chain functions (Warehouse/Logistic)</li><li>Excellent project management skills, planning, prioritization, ability to innovate and execute on solutions that matter, and provide timely updates/recommendations.</li><li>Good analytical, influencing and problem-solving skills and ability to handle team and client discussions.</li><li>Flexible to take on ad-hoc assignment or project as necessary.</li><li>Logical &amp; Analytical mindset with the ability to identify process improvement opportunities through data analysis.</li><li>Excellent communication skills, both written and verbal, to effectively collaborate with stakeholders and present complex concepts.</li><li>Understanding of process improvement methodologies such as Lean, Six Sigma, or Business Process Reengineering (BPR).</li><li>Familiarity with compliance and regulatory requirements related to business processes.</li></ul>

Role Description: <ul><li>The Procurement Specialist is responsible for managing the procurement of direct and indirect materials and services to ensure uninterrupted supply to manufacturing operations while achieving cost, quality, delivery, and working capital objectives. </li><li>The role partners closely with Production Planning, Operations, Quality, Finance, and Global Procurement to execute sourcing strategies, manage supplier performance, and support continuous improvement initiatives across the supply chain.&nbsp;</li><li>The successful candidate will have strong procurement execution skills, supplier management experience, and a proactive approach to resolving supply risks and driving operational excellence.&nbsp;</li></ul> Responsibilities: Procurement &amp; Supply Management&nbsp; <ul><li>Execute procurement activities for assigned direct materials, packaging materials, indirect spend categories, and services.</li><li>Convert purchase requisitions into purchase orders and manage end-to-end procurement transactions within SAP.</li><li>Ensure material availability to support production plans and customer commitments.</li><li>Monitor supplier delivery performance and proactively manage supply risks.</li><li>Coordinate with planning and operations teams to address shortages, delays, and capacity constraints.</li><li>Maintain optimal inventory levels in line with working capital and service objectives.&nbsp;</li></ul> Supplier Management&nbsp; <ul><li>Manage day-to-day supplier relationships and performance.</li><li>Monitor supplier KPIs including:&nbsp;&nbsp;On-Time Delivery (OTD), Quality performance, Lead time adherence, Responsiveness&nbsp;, Cost competitiveness</li><li>Conduct supplier performance reviews and support corrective action implementation where required.&nbsp;</li><li>Escalate supply risks and develop mitigation plans to ensure business continuity.</li></ul> Cost &amp; Contract Management <ul><li>Support sourcing initiatives and cost reduction projects.</li><li>Obtain quotations and conduct commercial evaluations.</li><li>Participate in supplier negotiations under guidance from Global Procurement or Supply Chain leadership.</li><li>Support implementation of payment term optimization initiatives.</li><li>Ensure contract pricing and procurement terms are accurately maintained within systems.&nbsp;&nbsp;</li></ul> Inventory &amp; Working Capital Management&nbsp; <ul><li>Collaborate with planning teams to optimize inventory levels.</li><li>Identify excess, obsolete, and slow-moving inventory risks.</li><li>Support inventory reduction initiatives without compromising customer service.</li><li>Monitor supplier lead times and MOQ impacts on inventory performance.</li></ul> SAP &amp; Process Excellence&nbsp; <ul><li>Maintain accurate procurement master data including:&nbsp;&nbsp;Vendor records, Pricing information, Lead times, Procurement parameters&nbsp;</li><li>Support SAP implementation and continuous process standardization initiatives.</li><li>Ensure compliance with procurement policies, approval authorities, and audit requirements.</li><li>Drive continuous improvement opportunities in procurement processes and supplier collaboration.</li></ul> Requirements:&nbsp; <ul><li>Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline.</li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred.</li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.</li><li>Experience in procurement or supply chain within a manufacturing environment.</li><li>Good understanding of supplier management, inventory control, and material planning (MRP).</li><li>Proficiency in SAP and Microsoft Excel for procurement and data analysis.</li><li>Strong communication, negotiation, and problem-solving skills.</li><li>Ability to collaborate effectively with cross-functional teams and suppliers.</li><li>Experience supporting cost-saving, process improvement, or SAP implementation initiatives.&nbsp;&nbsp;</li></ul>&nbsp;&nbsp;

Responsibilities: Order Management &amp; Fulfilment Execution <ul><li>Manage end-to-end order intake to fulfilment process ensuring alignment with customer requirements and supply capabilities.</li><li>Monitor and manage order backlog, ensuring timely resolution of constraints and prioritization.</li><li>Coordinate closely with Customer Support / Commercial teams on demand fulfilment and order commitments.</li><li>Drive proactive communication on order status, delays, and recovery plans.</li></ul> Supply Planning &amp; Prioritization <ul><li>Collaborate with Production Planners to translate demand into executable production and fulfilment plans.</li><li>Lead order prioritization decisions based on customer criticality, contractual commitments, and business impact.</li><li>Ensure optimal allocation of constrained supply across customers and regions.</li><li>Support escalation management for supply-demand imbalances.</li></ul> Capacity Planning &amp; RCCP <ul><li>Develop and maintain Rough-Cut Capacity Planning (RCCP) to ensure alignment between demand and production capacity.</li><li>Identify capacity constraints early and drive mitigation actions (e.g., alternate sourcing, schedule optimization, subcontracting).</li><li>Partner with manufacturing and procurement teams to balance load vs. capacity.</li></ul> Customer Stock Build &amp; Inventory Coordination <ul><li>Manage customer-specific stock build strategies to support service level targets and campaign demand.</li><li>Coordinate with inventory and warehouse teams to ensure optimal stock positioning Monitor and control inventory risks (excess, slow-moving, or shortages) linked to customer demand patterns.</li></ul> Cross-Functional Coordination (Control Tower Role) Act as the central coordination point between: <ul><li>Commercial / Demand Planning.</li><li>Customer Service o Production Planning.</li><li>Procurement / Logistics o Global Supply Chain team.</li><li>Drive alignment on order fulfilment strategies and execution plans.</li><li>Lead regular order fulfilment reviews and backlog governance meetings.</li><li>Performance Monitoring &amp; Continuous Improvement.</li></ul> Track and report key KPIs: <ul><li>OTIF (On-Time In-Full).</li><li>Backlog aging.</li><li>Service level adherence.</li><li>Capacity utilization.</li></ul> Identify root causes of service failures and drive corrective actions Lead or support initiatives to improve: <ul><li>Order cycle time.</li><li>Planning accuracy.</li><li>Supply chain responsiveness.</li></ul> Requirements: <ul><li>﻿Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline. </li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred. </li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.&nbsp;</li></ul>

Responsibilities: <ul><li>Be responsible for driving Cold Chain (Refrigeration) vertical sales in South-East Asia (SEA) region.</li><li>Manage the opportunity pipeline across accounts/territories in SEA region for Cold Chain (Refrigeration).</li><li>Lead, coach, and develop sales professionals to execute consultative, solutions-focused selling.&nbsp;</li><li>Drive Cold Chain (Refrigeration) account planning, prioritization, and deal execution to achieve revenue targets.&nbsp;</li><li>Provide in-depth product expertise on company offerings to support primary account owners during sales discussions.</li><li>Conduct product demonstrations and presentations for customers, highlighting key features and benefits.</li><li>Maintain disciplined use of CRM tools to manage pipeline visibility, forecasting, and account activity.&nbsp;</li><li>Collaborate cross-functionally with technical, marketing, and operations partners to deliver customer value.&nbsp;</li><li>Partner with country teams to grow company share of wallet with Key and Core customers</li><li>Collaborate with country teams to expand company market reach through direct and indirect customer appointments</li><li>Collaborate with the Product Marketing and Solutions teams to create customized solutions to meet specific customer needs</li><li>Drive new product launches in collaboration with the sales team</li><li>Assist in troubleshooting service and installation problems, offering technical support when needed</li><li>Analyze market trends and competitor activity to inform market strategies/product positioning to Product Marketing/Regional Leaders</li><li>Build and sustain strong relationships with key customer decision-makers within assigned markets.&nbsp;</li></ul> Requirements: <ul><li>Hold at least a Bachelor’s degree or higher, preferably in Mechanical/Electrical Engineering&nbsp;</li><li>Seven (7) years of experience in HVAC, refrigeration, or related technical sales environments.&nbsp;</li><li>Prior experience managing or leading account-aligned or territory-based sales teams.&nbsp;</li><li>Demonstrated ability to lead sales teams and deliver consistent revenue results.&nbsp;</li><li>Strong capability in opportunity management, pipeline management, and forecasting.&nbsp;</li><li>Experience coaching sellers in consultative and solutions-based sales approaches.&nbsp;</li><li>Ability to manage account strategies and prioritize resources to maximize growth.&nbsp;</li><li>Good verbal and written communication skills, fluent in Thai and English and good listening and computer skills.</li><li>Effective communication skills across customer, team, and internal stakeholder groups.&nbsp;</li><li>Independent with minimum supervision and a problem solver.</li><li>Legal authorization to work in Thailand – sponsorship will not be provided.&nbsp;</li></ul>

Responsibilities: <ul><li>Develop and execute procurement strategies to meet production and project requirements.</li><li>Analyse and provide feedback to appropriate departments on part status / requirements for fulfilling customer demand.</li><li>Manage delivery of critical component parts and product delivery with suppliers and contract manufacturing and critical supply partners to meet customer requirements.&nbsp;</li><li>Escalation of any issues to relevant sourcing analyst.</li><li>Monitor &amp; reporting KPI targets with actions– delivery on time, confirmation of purchase orders.</li><li>Invoice processing, resolving blocked invoices &amp; amendments of purchase orders</li></ul> Requirements: <ul><li>Educational Degree, Bachelor or above, Engineering background is preferred.</li><li>Minimum 5 – 7 years of experience in indirect procurement, experience in manufacturing company is a must.</li><li>Experience in at least 2 commodities including MRO, Facility, Automation line, HR services.</li></ul>

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</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>

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98 pharmaceutical supply chain Jobs found

Customer Service Specialist

Operator III, Packaging - 2nd Shift

Business Process Analyst – Purchasing

Business Process Analyst – Warehouse/Logistics

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Sales Manager (Cold Chain)

Strategic Sourcing III – Indirect Procurement

Process Engineering Manager

Site Quality Leader

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Skills

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98 pharmaceutical supply chain Jobs found

Customer Service Specialist

Operator III, Packaging - 2nd Shift

Business Process Analyst – Purchasing

Business Process Analyst – Warehouse/Logistics

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Sales Manager (Cold Chain)

Strategic Sourcing III – Indirect Procurement

Process Engineering Manager

Site Quality Leader

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