Manager, Quality – Sterile Operations

Amneal

18h • $110,000 - $145,000 • Onsite

About The Position

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.

Requirements

• Bachelors Degree (BA/BS) Pharmacy, Chemistry, Biotechnology, or a related field
• Minimum 5 years of experience in Quality Assurance/Quality Management in sterile pharmaceutical manufacturing, with at least 3 years in BFS operations.
• 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.
• Successful completion of an OSHA-compliant Respirator Fit Test.

Nice To Haves

• Master Degree (MS/MA) Pharmacy, Chemistry, Biotechnology, or a related field

Responsibilities

• 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.

Benefits

• comprehensive, flexible and competitive benefits program for eligible positions
• above-market, diverse and robust health and insurance benefits
• significant 401(k) matching contribution
• programs that helps you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees