To lead and oversee end-to-end Site Quality Assurance function , ensuring cGMP compliance, regulatory readiness, and robust Quality Management Systems , while supporting business objectives such as timely product release, audit success, and continuous quality improvement .
Quality Systems & Compliance

- Ensure effective implementation and sustenance of Quality Management Systems (QMS) across the site.
- Drive compliance with cGMP, regulatory guidelines (USFDA, MHRA, EU-GMP, WHO, CDSCO).
- Ensure site readiness for regulatory and customer audits at all times.
- Review and approve SOPs, BMRs, specifications, protocols, and quality documents.
- Audit & Regulatory Management
- Lead and manage regulatory inspections and audits (USFDA, MHRA, EU, TGA, etc.).
- Ensure timely closure of audit observations with robust CAPA implementation.
- Liaise with regulatory authorities and corporate quality for compliance matters.
- Product Quality & Release
- Ensure all products meet predefined quality specifications and regulatory requirements.
- Monitor stability studies, APQR/PQR, and product quality trends.
- Investigation & Risk Management
- Ensure effective investigation of deviations, OOS, OOT, complaints, and failures.
- Drive root cause analysis and CAPA effectiveness.
- Implement Quality Risk Management (QRM) across processes and systems.
- Ensure adherence to Validation Master Plan including process, cleaning, equipment,



and facility validation.
- Oversee qualification activities and ensure compliance with regulatory expectations.
- Partner with Production, QC, Engineering, R&D;, and Supply Chain to ensure quality and business alignment.
- Quality Transformation & Digital Initiatives
- Drive implementation of digital quality systems (e.g., Lead continuous improvement initiatives to enhance efficiency, compliance, and data integrity.
- Lead, mentor, and develop the Quality team to build a high-performance culture.
- Drive training programs for cGMP, quality awareness, and regulatory updates.
- Budgeting & Resource Management
- Manage Capex and Opex budgets for the Quality function.
- Key Performance Indicators (KPIs)

Audit outcomes (Regulatory & Customer)
Training effectiveness & quality culture index
Cost optimization within Quality function
Pharm / M.Pharm (Mandatory)
MBA / Six Sigma / Quality certifications (Preferred)
Experience

- 18–25 years in Pharmaceutical Quality Assurance
- Proven experience as Site Quality Head / QA Head in regulated plants
- Robust exposure to global regulatory audits (USFDA, MHRA, EU-GMP, etc.)

Strong knowledge of cGMP, QMS, regulatory requirements
Leadership and team management
Stakeholder management and influencing skills
Risk management and analytical thinking

📌 Director of Quality (QA & QC) (Diu)
🏢 Alkem Laboratories
📍 Diu