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, ensuring batch certification, release and compliance with cGMP and regulatory standards. This executive‑level position reports to the Quality Assurance Senior Manager and works closely with cross‑functional teams across the site.

Key responsibilities

• Act as Qualified Person (QP) for batch certification and release across manufacturing sites.
• Oversee QMS compliance, investigations, CAPA, change control and validation activities.
• Review and approve deviations, complaints, recalls and ensure timely completion of investigations in Ample Logic.
• Lead product lifecycle management including technology transfer, process validation, CPV and product discontinuation.
• Conduct site inspections, monitor self‑inspections and ensure GMP compliance of equipment, documentation and environmental conditions.
• Develop and deliver training programs for QA operations and ensure audit‑ready batch release documentation.

Required profile

• Bachelor of Pharmacy with a minimum of 10 + years experience in quality assurance for sterile manufacturing.
• Proven experience in batch release, product lifecycle management and QMS oversight.
• Strong knowledge of cGMP, cGXP and risk assessment methodologies.

Required skills

• cGMP compliance
• Quality Management System (QMS) operation
• Risk Assessment
• Ample Logic software for investigations and CAPA