Sterile Value Stream Manager (QAO)

About the role

The QAO 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.

Key responsibilities

• Act as Qualified Person (QP) for batch certification and release across manufacturing sites.
• Ensure cGMP compliance in documentation, gowning, environmental conditions, equipment calibration, and SOP adherence.
• Review and approve deviations, investigations, complaints, recalls, CAPA, and change control in Ample Logic.
• Conduct regular site inspections and monitor self‑inspections and GMP audit findings.
• Implement quality improvement plans and promote a strong quality culture with cross‑functional teams.
• Lead product lifecycle management, including technology transfer, process validation (PPQ), continued process verification (CPV), and product discontinuation.
• Oversee APQR/PQR trend analysis, stability programs, and lifecycle risk assessments.
• Review technical SOPs for adequacy and develop successors for the role.

Required profile

• Extensive experience in sterile pharmaceutical manufacturing quality assurance.
• Qualified Person (QP) status or equivalent regulatory qualification.
• Deep knowledge of cGMP, batch certification, and product lifecycle management.
• Proven ability to lead investigations, CAPA, and change control processes.
• Strong leadership and coaching skills for cross‑functional teams.

Required skills

• cGMP compliance
• Batch certification and release
• Process validation (PPQ)
• Continued Process Verification (CPV)
• CAPA management
• Change control
• Quality Management System (QMS) oversight
• Ample Logic system usage

What we offer

• Opportunity to lead quality strategy for a leading pharmaceutical company.
• Collaborative environment with cross‑functional teams.
• Competitive compensation package.