To lead and manage the overall Quality Assurance and CMO Quality function, ensuring product quality, GMP compliance, regulatory compliance, supply quality, and effective quality management across all internal and outsourced operations.
Key Responsibilities
1. CMO & Supply Quality
- Overall quality oversight of CMO/third-party manufacturing and supply activities.
- Review CMO quality performance, batch documentation, deviations, investigations and CAPA.
- Ensure timely and compliant batch record review and batch release.
2. Commercial QA
- Provide QA support for commercial product supply and customer requirements.
- Ensure quality requirements are fulfilled before product dispatch and supply.
3. Vendor Qualification & Audits
- Manage vendor qualification, approval and periodic requalification.
- Plan and conduct vendor audits and CMO audits.
- Review audit observations, CAPA and follow-up actions.
4. IPQA & Batch Documentation
- Ensure effective IPQA oversight of manufacturing and packing activities.
- Review and ensure compliance of BMR/BPR and related batch records.
- Ensure deviations and quality events are properly investigated and closed.
5. Warehouse, Dispatch & Export QA
- Ensure QA compliance for warehouse,
storage and material handling activities.
- Oversee dispatch QA and export documentation QA.
- Ensure products are dispatched only after completion of required quality checks and approvals.
6. Customer Quality & Complaints
- Manage customer complaints and ensure timely investigation and response.
- Coordinate with CMO and internal departments for quality issue resolution.
8. CAPA & Quality Systems
- Monitor deviations, investigations, CAPA and change controls.
- Ensure timely closure and effectiveness verification of CAPA.
- Identify quality risks and implement preventive improvements.
9. Audit & Inspection Readiness
- Ensure continuous inspection and customer audit readiness.
- Coordinate customer/CMO audits and ensure timely responses to observations.
- Prepare and review responses to CMO/customer audit findings.
10. Leadership & Governance
- Lead and develop the QA & CMO Quality team.
- Define QA KPIs and monitor quality performance.
- Coordinate with CMO, QC, Production, Supply Chain, Regulatory, Commercial and other functions to ensure uninterrupted and compliant product supply.