Website:
bgr-global.com
Job details:
Head – Quality & Regulatory Affairs | Biotech/Biologics/Vaccine | Mumbai]
Blue Genes Research (BGR), a global executive search and leadership advisory firm, is leading a confidential search for a senior leadership role with a globally recognised Biotech/Biologics/Vaccine manufacturer.
Role: Head – Quality & Regulatory Affairs
Location: Mumbai
Compensation: ₹70–100 LPA++
This strategic mandate reports directly to the Chairman & Managing Director, offering a rare opportunity to shape quality culture, lead regulatory strategy, and institutionalise world-class QMS and compliance frameworks across global markets including the USA, Europe, Japan, and China.
About the Organisation:
A global Biotech/Biologics/Vaccine leader manufacturing products certified to EN ISO 13485 and GMP standards, exporting to international regulated markets.
You Will:
- Build and drive enterprise-wide Quality & Regulatory frameworks aligned with ISO 13485, USFDA, WHO-PQ & EU MDR/IVDR standards
- Lead quality transformation initiatives and global compliance strategy
- Collaborate cross-functionally with R&D, manufacturing & leadership teams
- Represent the organisation before global regulatory authorities
- Champion continuous improvement, quality excellence & customer trust
Ideal Candidate:
- 18–20 years’ experience in Quality & Regulatory Affairs within IVD / Medical Devices / Diagnostics / Biotech / Biologics / Vaccine
- Must have good exposure to Quality control and Product development in early career
- Proven track record in USFDA or WHO-PQ–approved environments
- Lead Auditor (ISO 13485) certification preferred
- Strong leadership presence with experience managing multi-site operations
- Advanced degree in Life Sciences / Pharmacy / related discipline; MBA desirable
This is not a compliance maintenance role — it’s an opportunity to redefine quality strategy and partner directly with the CMD in a globally scaling organisation.
Click on Apply to know more.