Do you loathe unfinished work?
Are you a highly responsible person?
Are you a fixer?
Mega Lifesciences is looking for a Quality Assurance (QA) Director to work closely with the Chief Quality and Regulatory Officer in a fast-paced environment that offers ample opportunities to learn and expand your experience and expertise.
Job Summary
As QA Director, your key responsibilities include:
- Provide strategic leadership for the entire Quality Assurance function, owning the Quality Management System (QMS) for the site and ensuring robust cGMP compliance. Manage timely batch review, release, and disposition of pharmaceutical products.
- Develop and implement comprehensive QA strategies and governance frameworks, including policies, SOPs, performance metrics, and continuous improvement programs (Lean, Six Sigma, PDCA).
- Lead regulatory compliance and inspection readiness by hosting audits (US FDA, WHO-GMP, EU-GMP, TGA, and local agencies), managing timely CAPA closure, and sustaining zero-critical observations.
- Drive data-based effectiveness reviews, monitor key quality indicators, analyze deviations and complaints, and implement proactive risk mitigation across manufacturing processes.
- Build and mentor a high-performing QA team, ensuring capability enhancement, succession planning, and a culture of accountability and continuous learning.
- Act as the primary quality partner across all functions, influencing senior stakeholders and supporting new product, process, and system introductions while ensuring quality-by-design principles are integrated organization-wide.
Qualification & Experience
Applications are invited from interested candidates who meet the following criteria:
- Bachelor’s degree in Pharmacy (B.Pharm) is required; a Master’s degree in Pharmacy (M.Pharm) will be an added advantage.
- 15+ years of experience in Pharmaceutical QA, including 4–5 years in a senior leadership role at a manufacturing site.
- Expertise in QMS, including deviations, CAPA, change control, document control, validation, and APQR.
- Proven track record of managing and successfully closing international regulatory audits (US FDA, EU GMP, WHO GMP, TGA).
- Strong knowledge of cGMP, USP/BP/EP pharmacopoeias, regulatory requirements, and pharmaceutical manufacturing processes.
- Hands-on experience in sterile product QA is highly desirable.
Skills & Knowledge
The ideal candidate is structured, highly responsible, and an exceptional problem solver with strong leadership presence. They demonstrate unwavering integrity, sound judgment under pressure, and the ability to influence and collaborate with cross-functional leaders. Expertise in quality risk management (QRM), root cause analysis, batch disposition, and compliance leadership is essential. A proactive quality champion, the candidate continuously drives cultural change toward preventive quality and operational excellence while balancing compliance with business agility.
If you are eager to make the most of this opportunity, kindly fill in the details in respective fields and submit your application for the position.
For any further clarification and information related to the position, you may please contact +91 22 4141 7923 (Ms. Pradnya).