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Quality & Regulatory Affairs Specialist

maneuver-marketing · Singapore

New
Mid 🇬🇧 English
CAPA Stability testing NDI/GRAS Adverse event reporting

Job description

About the role

Maneuver Marketing, a DTC health and wellness brand that has grown from scratch to over $100M in annual sales, is hiring a Quality & Regulatory Affairs Specialist based in Singapore. Reporting to the Head of Product, you will be the technical backbone of the Product function, owning production quality oversight, troubleshooting, product testing and stability, and claims evidence. You will work hands-on with US and Australia-based CMO partners mostly remotely, holding finished-goods release sign-off.

Key responsibilities

  • Own quality oversight and production troubleshooting with CMO partners, set production and quality standards before manufacturing starts, review QC, consolidate batch records, close out CAPA and hold release sign-off
  • Handle adverse event reporting and audit CMO facilities when needed
  • Run stability testing and the accelerated and real-time stability program, from protocol review to launch sign-off
  • Generate claims evidence by scoping and managing benefit/proof studies (literature, clinical studies, CRO/IRB)
  • Determine NDI/GRAS/ODI status, permitted ingredients and dosage limits, maintain ingredient dossiers and scientific substantiation
  • Give technical input on ingredient sourcing, formulation feasibility and interaction/exposure checks, qualify new CMOs, suppliers and labs, and support batch-release readiness and marketing claims

Required profile

  • Scientific or technical background (food science, chemistry, nutrition, pharma/biotech or related)
  • Experience setting quality standards and managing quality through CMO/CDMO partners, including batch records, CAPA and release; direct facility auditing is a plus
  • Ability to interpret stability and ingredient testing data, COAs and QC results critically
  • Hands-on US ingredient and regulatory experience in a regulated consumer category (NDI/GRAS, FDA-adjacent compliance)
  • Experience scoping or managing benefit/claims studies with third-party labs or CROs
  • Comfortable as the sole technical voice in a commercially-led team, with sound judgement between quality and commercial reality and occasional night calls

Questions fréquentes

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Source : ats:ashby

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Published 18 hours ago

Expires 1 month from now

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maneuver-marketing

Singapore