Senior Product Quality Executive

About the role

We are seeking a Senior Product Quality Executive to lead the implementation and oversight of our Quality Management System across contract manufacturing organizations. The role ensures product quality, regulatory compliance, and readiness for commercial launch.

Key responsibilities

• Implement and maintain the QMS in line with internal policies, cGMP and global regulations.
• Manage quality operations and compliance for designated CMOs, adhering to Quality Technical Agreements.
• Lead complex OOS investigations, major deviations and risk assessments, driving timely CAPA closure.
• Review and approve critical product quality documents such as test protocols, analytical reports, batch records and process consistency data.
• Oversee complaint handling workflows, ensuring prompt investigation, trend reporting and metric analysis.
• Conduct internal audit programs and support external CMO/CRO audits for inspection readiness.
• Provide cross‑functional training on quality procedures and mentor junior QA staff.

Required profile

• Degree in Biomedical/Bioprocess Engineering or Biology/Chemistry.
• 6‑8+ years progressive experience in biopharmaceutical quality assurance.
• Hands‑on familiarity with upstream and downstream bioprocessing technologies.
• Proven experience managing external manufacturing partners (CMOs) and handling technical deviations.

Required skills

• cGMP compliance
• Quality Management System (QMS)
• CAPA and OOS investigation processes
• Bioprocessing technology (upstream & downstream)
• Batch record review and analytical reporting
• Quality Technical Agreements