Manager - Quality OSD Value Stream

About the role

The Manager – Quality OSD Value Stream will provide end‑to‑end Quality Assurance oversight across pharmaceutical manufacturing sites, act as the Qualified Person for batch certification and release, and lead product lifecycle management activities in line with cGMP, regulatory requirements and company quality standards.

Key responsibilities

• Ensure cGMP compliance by monitoring documentation practices, gowning attire, cleanliness, equipment calibration, and adherence to SOPs and manufacturing instructions.
• Review and approve deviation investigations, complaints, recalls and ensure timely completion in Ample Logic.
• Review, approve and drive implementation of CAPA and change controls for related plants.
• Conduct regular site inspections, monitor self‑inspections and GMP inspection CAPA compliance.
• Implement the Quality Improvement Plan and promote a strong quality culture across cross‑functional teams.
• Approve Batch Manufacturing Records (BMR) and related batch documentation.

Required profile

• Minimum 120 months (10 years) of experience in pharmaceutical quality assurance.
• Experience with batch certification, release processes and product lifecycle management.
• Familiarity with Ample Logic for investigations, CAPA and change control management.
• Proven ability to conduct site inspections and ensure GMP compliance.

Required skills

• Change Control
• Good Documentation Practices
• Risk Assessment
• Technology Transfer
• Process Validation
• QMS systems
• Audit Readiness
• Product Lifecycle Management
• cGMP Compliance
• CAPA
• Quality Assurance