Job DescriptionWe're Hiring | Vice President – Quality & Regulatory Affairs
nMumbai | Regulated Life-Sciences Manufacturing | USFDA & WHO-PQ approved
nBGR 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.
nThe Role
nSecond-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.
nWhat you'll own
n• Execute and strengthen the QMS under EN ISO 13485, ISO 9001, USFDA 21 CFR 820, and WHO-PQ
n• Drive shop-floor QC across the full manufacturing cycle
n• Lead internal audits and front-line responses to USFDA, notified body, WHO, and customer audits
n• Own KPIs — batch rejection, RFT, deviation & CAPA closure, complaints, non-conformances
n• Drive regulatory submissions, product registrations,



variations, renewals, and change notifications across USA, Europe, Japan, China, and RoW
n• Monitor regulatory intelligence; assess impact of evolving regulations on product compliance
n• Ensure compliance with labelling, IFU, post-market surveillance, and vigilance / adverse-event reporting
n• Partner with R&D; on Design Control, DHF/DMR, ISO 14971 risk management, and IQ/OQ/PQ validation
n• Run the supplier qualification, audit, and scorecard programme
n• Own end-to-end customer complaint handling and CAPA closure
n• Lead, coach, and build depth in a 20+ member QA / QC / RA / Documentation team
nWhat we're looking for
n• 12–15 years in Quality & Regulatory Affairs within a USFDA / WHO-PQ approved manufacturing setting
n• Biologicals, biotech, pharma, or regulated life-sciences manufacturing background preferred
n• Proven experience as a lead responder in regulatory and custome

📌 Vice President (Maharashtra)
🏢 Blue Genes Research (BGR)
📍 Maharashtra