Head Quality Assurance

Alkem Laboratories Ltd.; Daman; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Alkem Laboratories Ltd. in India seeks a seasoned Site Quality Head to lead the end-to-end quality assurance function, ensuring cGMP compliance, regulatory readiness, and robust QMS across the site.

You will oversee regulatory inspections, audit success, and continuous quality improvement while collaborating with cross-functional teams to support timely product release and strong CAPA execution.

Qualifications

• B.Pharm or M.Pharm is mandatory.
• Experience as Site Quality Head / QA Head in regulated plants.
• Exposure to global regulatory audits (USFDA, MHRA, EU-GMP).

Responsibilities

• Lead and oversee end-to-end Site Quality Assurance function, ensuring cGMP compliance and regulatory readiness.
• Drive and manage regulatory inspections and audits (USFDA, MHRA, EU, TGA).
• Review and approve SOPs, BMRs, specifications, protocols, and quality documents.
• Oversee batch disposition and final product release for distribution.
• Monitor stability studies, APQR/PQR, and product quality trends.
• Drive Quality Risk Management (QRM) across processes and systems.
• Ensure adherence to Validation Master Plan including process, cleaning, equipment, and facility validation.
• Lead, mentor, and develop the Quality team to build a high-performance culture.

Skills

cGMP knowledge

QMS knowledge

Leadership

Regulatory understanding

Risk management

Stakeholder management

Analytical thinking

Integrity/compliance mindset

Education

B.Pharm / M.Pharm

MBA / Six Sigma / Quality certifications

Tools

eQMS

LMS

Veeva

Job description

Job Description

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.

Key Responsibilities

• 1. 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.
• 2. 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.
• 3. Product Quality & Release
• Ensure all products meet predefined quality specifications and regulatory requirements.
• Oversee batch disposition and final product release for distribution.
• Monitor stability studies, APQR/PQR, and product quality trends.
• 4. 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.
• 5. Validation & Qualification
• Ensure adherence to Validation Master Plan including process, cleaning, equipment, and facility validation.
• Oversee qualification activities and ensure compliance with regulatory expectations.
• 6. Cross-functional Collaboration
• Partner with Production, QC, Engineering, R&D, and Supply Chain to ensure quality and business alignment.
• Support technology transfer, product launches, and scale-ups.
• 7. Quality Transformation & Digital Initiatives
• Drive implementation of digital quality systems (e.g., eQMS, LMS, Veeva).
• Lead continuous improvement initiatives to enhance efficiency, compliance, and data integrity.
• 8. Team Leadership & People Development
• Lead, mentor, and develop the Quality team to build a high-performance culture.
• Drive training programs for cGMP, quality awareness, and regulatory updates.
• Ensure strong people engagement and retention within the function.
• 9. Budgeting & Resource Management
• Manage Capex and Opex budgets for the Quality function.
• Optimize resource utilization while maintaining compliance and efficiency.

Key Performance Indicators (KPIs)

• Audit outcomes (Regulatory & Customer)
• Deviation, OOS, CAPA closure timelines
• Batch release cycle time
• Compliance score / inspection readiness
• Training effectiveness & quality culture index
• Cost optimization within Quality function

Educational Qualification

• B.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
• Strong exposure to global regulatory audits (USFDA, MHRA, EU-GMP, etc.)

Key Skills & Competencies

• Strong knowledge of cGMP, QMS, regulatory requirements
• Leadership and team management
• Decision-making and problem-solving
• Stakeholder management and influencing skills
• Risk management and analytical thinking
• High integrity and compliance mindset