Blue Genes Research (BGR) · India

' | – &

Mumbai | Regulated Life-Sciences Manufacturing | USFDA & WHO-PQ approved

BGR is retained by a globally respected life-sciences manufacturer (established for over three decades) with exports to the USA, Europe, Japan, and China, to identify their next Vice President – Quality & Regulatory Affairs.

Second-in-command of the Quality & Regulatory function. Reporting to the Head of Quality & Regulatory, you will own day-to-day quality and regulatory operations across manufacturing, QC, QA, documentation, regulatory submissions, and supplier quality — and be groomed for succession.

'

• Execute and strengthen the QMS under EN ISO 13485, ISO 9001, USFDA 21 CFR 820, and WHO-PQ

• Drive shop-floor QC across the full manufacturing cycle

• Lead internal audits and front-line responses to USFDA, notified body, WHO, and customer audits

• Own KPIs — batch rejection, RFT, deviation & CAPA closure, complaints, non-conformances

• Drive regulatory submissions, product registrations, variations, renewals, and change notifications across USA, Europe, Japan, China, and RoW

• Monitor regulatory intelligence; assess impact of evolving regulations on product compliance

• Ensure compliance with labelling, IFU, post-market surveillance, and vigilance / adverse-event reporting

• Partner with R&D on Design Control, DHF/DMR, ISO 14971 risk management, and IQ/OQ/PQ validation

• Run the supplier qualification, audit, and scorecard programme

• Own end-to-end customer complaint handling and CAPA closure

• Lead, coach, and build depth in a 20+ member QA / QC / RA / Documentation team

'

• 12–15 years in Quality & Regulatory Affairs within a USFDA / WHO-PQ approved manufacturing environment

• Biologicals, biotech, pharma, or regulated life-sciences manufacturing background preferred

• Proven experience as a lead responder in regulatory and customer audits

• Hands-on experience with dossier preparation and regulatory submissions across US, EU, and RoW markets

• Deep working knowledge of Design Control, CAPA, Change Control, Validation, PMS, and vigilance reporting

• M.Sc. / M.Pharm in Chemistry, Microbiology, Biotechnology, or Life Sciences (Ph.D. / MBA / Six Sigma a plus)

• Strong people leadership; multi-site or multi-product exposure an added advantage

A defined career path with succession into the Head of Quality & Regulatory role for the right candidate, in a market-leading, globally exporting organisation.