MANAGER QUALITY (5023)

The Manager, Quality Assurance is accountable for the performance and compliance of assigned quality systems and operational areas within a regulated contract manufacturing environment. This position provides final quality review and disposition decisions for raw materials, in-process materials, and finished goods, ensuring products meet established specifications, regulatory requirements, and customer expectations. Key Responsibilities Quality System Ownership & Decision Authority Own and maintain assigned quality systems, including but not limited to deviations, investigations (OOS/OOT), CAPA, change control, batch record review, and product disposition Provide final quality review and release/disposition decisions for materials and finished products Exercise independent decision-making authority for routine and non-routine quality events, ensuring compliance with cGMP and customer requirements Escalate significant quality risks (e.g., recall risk, critical events) in accordance with established procedures Manufacturing Quality Oversight Provide QA oversight of liquid fill manufacturing operations to ensure compliance with cGMPs, internal procedures, and customer-specific requirements Support real-time decision-making on the production floor related to deviations, non-conforming materials, and process issues Ensure effective execution of in-process controls and finished product inspection requirements Contract Manufacturing Quality Leadership Serve as the primary Quality representative for assigned contract manufacturing customers Lead customer quality discussions, governance meetings, and issue resolution calls independently Own all customer quality communications, including: Deviations and investigations Complaint responses Customer notifications and regulatory commitments Prepare and review customer‑specific documentation, including: Questionnaires and technical requests Specifications and supporting quality data Audit responses and follow-up documentation Lead and/or support customer audits, ensuring transparency, professionalism, and inspection readiness Compliance & Regulatory Oversight Ensure compliance with applicable regulatory requirements, including FDA, EPA, DNR, ATF, and OSHA Maintain inspection readiness at all times; support and lead regulatory inspections and customer audits Ensure adherence to data integrity principles (ALCOA+) across all quality systems and documentation Ensure consistent and compliant application of site procedures and quality standards Investigation & Risk Management Lead and approve investigations, including OOS, OOT, deviations, and nonconformances Ensure robust root cause analysis and implementation of effective corrective and preventive actions Monitor and trend quality data to identify emerging risks and drive proactive improvements Apply risk-based decision making consistent with ICH Q9 principles Validation & Change Control Oversight Ensure validation programs comply with regulatory requirements and internal procedures Oversee quality impact assessments and approvals within the change control system Ensure appropriate evaluation of changes for regulatory, product quality, and customer impact Leadership & Personnel Management Directly supervise and develop quality personnel, including both hourly and salaried employees Ensure effective training, qualification, and ongoing development of staff Provide performance management, coaching, and leadership to drive a high‑performing quality organization Foster a culture of accountability, ownership, and continuous improvement Operational Support & Continuous Improvement Partner cross‑functionally with Manufacturing, Supply Chain, Engineering, and R&D to resolve quality issues and improve performance Drive continuous improvement initiatives to enhance product quality, reduce variability, and improve efficiency Support site quality metrics and ensure alignment with business and customer expectations Qualifications Education Bachelor’s degree in Chemistry, Microbiology, Engineering, or related scientific discipline required Experience Minimum 10 years of experience in a regulated industry (OTC drug, pharmaceutical, cosmetic, or similar) Minimum 5 years of progressive leadership experience in Quality Assurance or Quality Systems Demonstrated experience supporting FDA inspections and customer audits Experience in a contract manufacturing environment strongly preferred Knowledge, Skills, and Abilities Strong knowledge of cGMP requirements (21 CFR Parts 210/211) and quality system expectations Demonstrated ability to make independent, risk‑based quality decisions Strong investigation skills, including root cause analysis and CAPA effectiveness Excellent technical writing and documentation skills Strong communication skills with the ability to interface effectively with customers and all levels of the organization Ability to manage multiple priorities in a fast‑paced manufacturing environment High level of accountability, ownership, and professional judgment Work Environment Work is performed in a combination of office, laboratory‑adjacent, and manufacturing environments Regular exposure to production areas with varying temperatures, noise levels, and proximity to operating equipment Required use of appropriate personal protective equipment (PPE) Physical Demands Regularly required to stand, walk, use hands, and communicate effectively Frequently required to move throughout manufacturing and warehouse areas Occasional lifting of materials up to 40–50 pounds; frequent handling of light samples (1–5 pounds) Requires visual acuity for detailed review of documentation and inspection activities, including ability to distinguish color and fine detail #J-18808-Ljbffr