Manager, Quality – Sterile Operations

Description:

The Sterile BFS QA/QM Manager is responsible for leading all Quality Assurance (QA) and Quality Management (QM) 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 (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) 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 (Food and Drug Administration) 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, Corrective and Preventative Action (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 analyzes (e.g., Failure Modes and Effects Analysis {FMEA}), monitoring quality metrics, and implementing proactive risk mitigation and process optimization strategies.

Education:

• Bachelors Degree (BA/BS) Pharmacy, Chemistry, Biotechnology, or a related field - Required
• Master Degree (MS/MA) Pharmacy, Chemistry, Biotechnology, or a related field - Preferred

Experience:

• 5 years or more in Minimum 5 years of experience in Quality Assurance/Quality Management in sterile pharmaceutical manufacturing, with at least 3 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.

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $110,000 to $145,000 per year.   Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.