Manager, Quality - Sterile Operations

Position Overview Sterile BFS QA/QM Manager – responsible for leading all Quality Assurance and Quality Management functions within a sterile Blow‑Fill‑Seal (BFS) manufacturing environment. The manager will oversee quality operations, drive continuous improvement initiatives, manage internal and external audits, and ensure a state of inspection readiness. Essential Functions Design, review, and approve protocols for media fills to validate that the BFS or bag‑filling process consistently produces sterile products. Provide quality oversight for validation lifecycle activities, including Installation Qualification, Operational Qualification, and Performance Qualification for BFS machines and bag‑filling lines. Monitor the Grade A environment, clean utility systems (WFI, clean steam), and ensure proper sterilization cycles (CIP/SIP) for the equipment. Analyze EM data for cleanrooms and surrounding areas, ensuring microbial counts are within limits. Review batch records, manufacturing, and packaging documentation for compliance with cGMP to ensure product safety. Evaluate the impact of proposed changes to manufacturing equipment, processes, or materials. Lead investigations into sterility failures, unexpected deviations, or breaches in aseptic conditions, implementing Corrective and Preventive Actions (CAPA). Ensure full compliance with Current Good Manufacturing Practices (cGMP) and global regulatory requirements (FDA) by maintaining a state of audit readiness and serving as the Quality Assurance lead during inspections, audits, and regulatory engagements. Oversee core quality processes including batch record review, deviation investigations, CAPA, change control, and complaint management to ensure timely and effective resolution. Review and approve validation documentation for equipment, processes, and cleaning activities, ensuring adherence to internal quality standards and regulatory expectations. Manage site quality systems such as document control, training programs, product quality reviews, and support quality oversight during tech transfers, scale‑up, and new product introductions for BFS lines. Drive continuous improvement initiatives by leading root cause analyses (e.g., Failure Modes and Effects Analysis), monitoring quality metrics, and implementing proactive risk mitigation and process optimization strategies. Qualifications Bachelor’s degree (BA/BS) in Pharmacy, Chemistry, Biotechnology, or a related field is required; an advanced degree is preferred. Experience Minimum five years in Quality Assurance/Quality Management in sterile pharmaceutical manufacturing, with at least three years in BFS operations. Specialized Knowledge In‑depth knowledge of sterile manufacturing and BFS/Bag line technology. Strong understanding of cGMP, FDA, EMA, and ICH guidelines. Proficiency in quality systems (CAPA, change control, deviation management). Excellent leadership, communication, and problem‑solving skills. Ability to manage cross‑functional teams and projects. Requirements Successful completion of an OSHA‑compliant Respirator Fit Test. Salary and Benefits Annual salary range: $110,000 – $145,000. Benefits include health, dental, and vision insurance, a 401(k) plan with company match, and standard company benefits. Equal Opportunity Employer Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, or any other characteristic protected by applicable federal, state, or local laws. #J-18808-Ljbffr Amneal Pharmaceuticals