QAO Sterile Value Stream Manager

About the role

The QAO Sterile Value Stream Manager will lead end‑to‑end quality assurance for sterile pharmaceutical manufacturing. This role acts as the Qualified Person (QP) for batch certification and release, ensuring compliance with cGMP, regulatory requirements and company quality standards throughout the product lifecycle.

Key responsibilities

• Provide QA oversight across all sterile manufacturing sites, including batch certification, release and product lifecycle management.
• Monitor cGMP compliance: documentation practices, gowning, environmental conditions, equipment calibration, SOP adherence and manufacturing instructions.
• Review and approve deviations, investigations, complaints, recalls and CAPA actions, ensuring timely completion in Ample Logic.
• Approve change control assessments, BMR/BPR documentation and oversee technology transfer, process validation (PPQ) and continued process verification (CPV).
• Conduct regular site inspections, self‑inspections and GMP audit follow‑ups, driving continuous improvement and quality culture.
• Lead batch document audits, retention sample checks and final shipment verifications, including quarantine releases.

Required profile

• Qualified Person (QP) status or equivalent certification for sterile pharmaceutical products.
• Extensive experience with cGMP regulations, QMS, batch release and product lifecycle management.
• Proven ability to manage investigations, CAPA, change control and validation activities.
• Strong knowledge of risk assessment, SOP review and GMP documentation.

Required skills

• cGMP compliance
• Qualified Person (QP) certification
• Quality Management System (QMS) expertise
• CAPA management
• Change control processes
• Process validation (PPQ) and Continued Process Verification (CPV)
• Product lifecycle management
• Ample Logic quality system

What we offer

• Leadership role in a global sterile manufacturing environment.
• Opportunity to shape quality culture and drive continuous improvement.
• Collaboration with cross‑functional teams across the product lifecycle.