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
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- Execute and strengthen the QMS under EN ISO 13485, ISO 9001, USFDA 21 CFR 820, and WHO-PQ
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- Drive shop-floor QC across the full manufacturing cycle
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- Lead internal audits and front-line responses to USFDA, notified body, WHO, and customer audits
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- Own KPIs — batch rejection, RFT, deviation & CAPA closure, complaints, non-conformances
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- Drive regulatory submissions,



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

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