Sterile Value Stream Manager (Quality Assurance)

About the role

The Sterile Value Stream Manager will lead end‑to‑end quality oversight for sterile pharmaceutical manufacturing. Reporting to senior quality leadership, the role acts as the Qualified Person (QP) for batch certification and release while ensuring compliance with cGMP, regulatory requirements, and company standards.

Key responsibilities

• Provide QP oversight for batch certification, release, and product lifecycle management across manufacturing sites.
• Monitor cGMP compliance in all manufacturing activities, including documentation, gowning, environmental conditions, equipment calibration, and SOP adherence.
• Review and approve deviations, investigations, complaints, recalls, CAPA, and change control in the Ample Logic system.
• Conduct regular site inspections and ensure timely implementation of CAPA and self‑inspection findings.
• Lead quality improvement initiatives, promote a quality culture, and coordinate cross‑functional teams.
• Oversee product lifecycle activities such as technology transfer, process validation (PPQ), commercial manufacturing, CPV, and product discontinuation.
• Approve batch manufacturing records (BMR/BPR) and ensure proper document retention and audit.

Required profile

• Extensive experience in pharmaceutical quality assurance, preferably in sterile manufacturing.
• Strong knowledge of cGMP, regulatory guidelines, and batch release processes.
• Proven ability to lead investigations, CAPA, and change control activities.
• Excellent understanding of product lifecycle management and validation concepts.

Required skills

• Ample Logic quality management system