Head of Quality

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: 70100 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:

• 1820 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-PQapproved 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.