Role : Lead CQA ( Formulations - OSD & Sterile)
Designation : General Manager
Department : CQA

Role Objective:

Direct the strategic implementation, governance, and advancement of the corporate Quality Management System (QMS) across internal facilities and Contract Manufacturing Organizations (CMOs).
This executive position ensures global regulatory compliance, risk mitigation, and quality excellence through cross-functional leadership and external partnership management. Utilizing expertise in QA, QC, and Microbiology, the lead will drive audit readiness.
KEY RESPONSIBILITIES
- QMS Approval & Compliance: Review and approve core Quality Management System elements (including Change Controls, Deviations, Investigations, Market Complaints, Product Recalls, Specifications, BMR/MFR, Stability Protocols/Reports, Validation Master Plans, and APQRs) to ensure a continuous state of regulatory compliance.
- Market Complaint & Counterfeit Investigation: Spearhead investigations into market complaints and hub observations; define and track the effectiveness of CAPA. Coordinate with local FDA,



cross-functional teams (CFT), and marketing to resolve identified counterfeit product issues.
- Recall & NSQ Tracking: Manage, execute, and monitor product recall processes and track Not of Standard Quality (NSQ) matters until complete closure.
- Contract Manufacturing Oversight: Ensure stringent adherence to Good Manufacturing Practices (GMP) across USV’s Loan License (LL) and Third Party (TP) contract manufacturing locations by approving audit agendas and conducting quality/cause audits.
- Regulatory & Guideline Implementation: Coordinate with sites and CFTs to seamlessly deploy current guidelines and mandatory requirements (e.g., Revised Schedule M, Psychotropic substances, QR Codes, DEG, and EG compliance).
- Quality Agreements & Governance: Review and align Quality Agreements with customers and legal departments. Organize Site Quality review meetings, prepare corporate Quality Review Com

📌 General Manager (Govandi East)
🏢 USV
📍 Govandi East