SENIOR MANAGER – CORPORATE QUALITY
JOB DESCRIPTION:
Packaging & Commercial Operations
- Approval of commercial artwork finalization and packaging development for all markets.
- Approve and maintain Code lists, Packing material specifications and Methods of Analysis
- Address packaging‑related customer complaints and implement corrective actions.
- Reviews andfollow up with vendors forjustification / CAPA for on line rejections andComplete rejections.
- Ensure standardization and compliance of packaging materials.
Vendor & Loan License Management
- Lead qualification, surveillance, and follow‑up audits for Packing Material and Loan License sites.
- Approve or deregister vendors in collaboration with Procurement and QA.
- Monitor vendor performance and ensure timely CAPA implementation.
Quality Systems & Compliance
- Ensure compliance to global regulations (e.g., 21 CFR, EU GMP, WHO, MHRA).
- Own change controls, deviations, and audit observation closures in assigned areas.
- Represent function during regulatory and client audits.
- Ensure documentation integrity within DMS, SAP, and Quality systems.
People & Capability Leadership
- Set performance goals, allocate work, and drive productivity.
- Build a strong compliance culture and continuous improvement mindset.
Financial & Administrative
- Manage audit and compliance budgets for packaging material vendors and loan license sites.
- Ensure cost‑effective execution without compromising quality or compliance.
Key Interfaces
- Internal: QA, QC, Packaging, Procurement, Manufacturing, BD, Regulatory
- External: Vendors, Loan License Partners, Clients, Regulatory Authorities
Qualifications & Experience
- Graduate in Science/ Pharmacy with Diploma in Packaging or Analytical Chemistry
- 14-16 years of experience in pharmaceutical packaging, vendor management, and quality systems
- Reasonable exposure to regulatory audits and multi‑market compliance
Key Competencies
- Regulatory & cGMP Experience in directly facing inspectors/auditors.
- Vendor & Audit Management
- Packaging & Artwork Governance
- Stakeholder Influence & Decision Making
