The Role
We’re hiring a Quality & Regulatory Affairs Specialist to be the technical backbone of our Product function, mainly Product Operations.
Reporting to the Head of Product, you’ll own production quality oversight, troubleshooting, product testing and stability, and claims evidence, with US ingredient and regulatory requirements as a required supporting skillset.
This is a hands‑on, individual‑contributor role for someone comfortable being the only technical voice in a commercially‑led team and managing quality through contract manufacturers rather than an owned plant.
Based in Singapore, you’ll manage US and Australia‑based CMO partners mostly remotely (occasional travel and some night calls given US time zones) and hold finished‑goods release sign‑off. Ultimately, you’ll help us ship products that enrich customers’ lives, made safely, within each market’s laws, on time, and with a mindset that supports the whole team.
What You’ll Do
Own quality oversight and production troubleshooting
- Diagnose and resolve production quality problems with our CMO partners, and set production/quality standards before a new product goes into manufacturing
- Review production QC, consolidate batch records, close out CAPA, and hold finished‑goods release sign‑off
- Own adverse event reporting (AER); audit CMO facilities when needed
Verify products and run stability testing
- Interpret identity, potency, and probiotic viability results to confirm each product matches its label and holds to end of shelf life
- Manage the accelerated and real‑time stability program end to end, from protocol review to launch sign‑off
- Scope and manage benefit/proof studies on existing products (literature, clinical studies, CRO/IRB) to strengthen what we can say about them
Carry US ingredient and regulatory requirements
- Determine NDI/GRAS/ODI status and confirm permitted ingredients, dosage limits, and market requirements
- Maintain ingredient dossiers and scientific substantiation
Cross Functional Collaborations
- Give technical input on ingredient sourcing, formulation feasibility, and interaction/exposure checks; technically qualify new CMOs, suppliers, and labs
- Partner with supply chain on batch‑release readiness, give marketing substantiated claims language, and give customer service credible technical answers
What We’re Looking For
- A scientific/technical background (food science, chemistry, nutrition, pharma/biotech, or related)
- Experience setting production quality standards and managing quality through CMO/CDMO partners — batch records, CAPA, release — rather than an owned site (direct facility auditing a plus)
- Able to interpret stability and ingredient testing data (probiotic or botanical a plus), COAs, and QC results critically — you won’t design assays, but you must know what the data means
- Hands‑on US ingredient/regulatory experience in a regulated consumer category — NDI/GRAS, permitted ingredients, FDA‑adjacent compliance (claim wording handled by our consultant)
- Experience scoping or managing benefit/claims studies with third‑party labs or CROs
- Comfortable as the sole technical voice — independent, process‑literate in a stage‑gate system, and communicating clearly with commercial leaders
- Sound, D2C‑agile judgement between quality and commercial reality; comfortable with occasional night calls to coincide with US partners
What Success Looks Like
- CMO standards set up front; batch records pass review with no repeat findings
- Stability and testing data ready ahead of every finished‑goods release
- Claims and labels clear regulatory review with no compliance‑driven launch delays
- Existing products gain stronger claims evidence over time
- Product Innovation and Product Operations have a trusted technical partner in every major decision