Manager, Quality – Sterile Operations

Amneal•Yaphank, NY

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

Experience in a sterile Blow-Fill-Seal (BFS) manufacturing environment.
Experience with Quality Assurance (QA) and Quality Management (QM) functions.
Experience with media fills to validate sterile product production.
Experience with validation lifecycle activities (IQ, OQ, PQ) for BFS machines and bag-filling lines.
Knowledge of Grade A environment monitoring, clean utility systems (WFI, clean steam), and sterilization cycles (CIP/SIP).
Ability to analyze EM data for cleanrooms and surrounding areas.
Experience reviewing batch records, manufacturing, and packaging documentation for cGMP compliance.
Ability to evaluate the impact of changes to manufacturing equipment, processes, or materials.
Experience leading investigations into sterility failures, deviations, or aseptic breaches.
Experience implementing Corrective and Preventive Actions (CAPA).
Knowledge of Current Good Manufacturing Practices (cGMP) and global regulatory requirements (Food and Drug Administration).
Experience managing audits and regulatory inspections.
Experience overseeing batch record review, deviation investigations, CAPA, change control, and complaint management.
Experience reviewing and approving validation documentation for equipment, processes, and cleaning.
Experience managing site quality systems including document control, training programs, and product quality reviews.
Experience supporting quality oversight during tech transfers, scale-up, and new product introductions for BFS lines.
Experience driving continuous improvement initiatives.
Experience leading root cause analyses (e.g., Failure Modes and Effects Analysis FMEA}).
Ability to monitor quality metrics and implement risk mitigation and process optimization strategies.

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.