
Senior Director of Quality Assurance
3 days ago
The ideal candidate will oversee the implementation of a robust quality management system across R&D and manufacturing operations. This position requires a strategic leader with expertise in QA, regulatory compliance, and technology transfer.
The successful candidate will drive a culture of quality ownership, data integrity, and right-first-time execution across R&D and manufacturing units.
Key Responsibilities- Strategic Leadership: Define and implement the quality strategy for India Operations covering R&D (Discovery Chemistry, Process R&D) and the Manufacturing Plant.
- Quality Systems & Regulatory Compliance: Establish and maintain a robust Quality Management System to comply with global regulatory frameworks.
- R&D & Manufacturing Interface: Provide quality oversight for tech transfer activities from R&D to the manufacturing plant.
- A Master's degree in Pharmaceutical Sciences / Chemistry / Life Sciences; Ph.D. preferred.
- 20+ years of progressive QA experience in pharmaceutical / biotech / CDMO organisations, with at least 5–7 years in a senior leadership role.
- Strong track record in R&D QA (Discovery & Process Research) and Manufacturing QA within a regulated environment.
- In-depth understanding of global regulatory frameworks (USFDA, EMA, MHRA, ICH, OECD-GLP, cGMP).
This role offers an exciting opportunity to work in a dynamic environment and contribute to the success of the organization.
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