Quality & Regulatory Compliance Manager
Listed on 2026-01-12
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
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O Positiv Health is a Los Angeles‑based women’s health company on a mission to support women through every stage of life—from their first period to well beyond their last. Since launching in 2018, O Positiv has reshaped the women’s health space, tackling long‑overlooked issues with innovative, science‑backed products and boldly breaking taboos along the way. Our growing portfolio spans PMS & hormone balance, vaginal & urinary health, digestion, menopause, and conception support—offering vitamins, supplements, and personal care products that women trust.
Today, O Positiv products are sold nationwide at Target, Walmart, CVS, Amazon, Tik Tok Shop, and We’re proud to hold the #1 Vaginal Probiotic nationwide and multiple top‑performing products across major wellness categories. We are scaling fast and shaping the future of women’s health.
Your RoleWe’re looking for an experienced and detail‑oriented Quality & Regulatory Compliance Manager to oversee the quality and compliance of our growing line of vitamins, supplements, and personal care products. This is a cross‑functional role that will work closely with Procurement, R&D, Legal, and our external contract manufacturing partners to ensure our products meet the highest standards of safety, efficacy, and regulatory compliance.
Responsibilitiesand Duties
- Lead all QA activities across our contract manufacturing network, ensuring full compliance with relevant regulatory standards
- Develop, implement, and maintain a robust Quality Management System (QMS) tailored to the needs of the business
- Lead annual audit processes for all contract manufacturing partners to verify regulatory compliance (including documentation review and on‑site inspections, where applicable)
- Review and approve product specification sheets and ensure alignment across R&D, suppliers, and co‑manufacturers
- Review and approve Certificates of Analysis (CoAs), investigating and resolving any out‑of‑spec results in collaboration with co‑manufacturers
- Manage third‑party labs and testing facilities for microbiological, stability, and compatibility testing
- Investigate and resolve quality issues, including product non‑conformance, consumer complaints, and manufacturing deviations
- Develop, maintain, and enforce quality agreements and SOPs with all co‑manufacturers
- Serve as primary QA contact for internal cross‑functional teams and external co‑manufacturers on all product quality or compliance issues
- Stay current on evolving supplement regulations and proactively adjust internal processes to remain in compliance
- Support documentation and regulatory submissions for new market launches
- Evaluate and qualify new manufacturer partners in collaboration with Operations and R&D, including supplier qualification evaluations, risk assessments, and review of quality measures
- Review, maintain, and archive raw material, packaging, and relevant quality documentation for all SKUs, including specs, certificate of analysis, and regulatory certificates, ensuring proper filing and audit readiness
- 5+ years of experience in Quality Assurance and Regulatory Compliance, with a focus on dietary supplements
- Deep familiarity with FDA 21, CFR Part 11 and cGMP regulations and third‑party certification standards
- Experience managing contract manufacturing partners, inspections, and regulatory readiness
- Strong understanding of formulation, product stability, ingredient sourcing, and supplement production processes and regulatory requirements
- Meticulous attention to detail, with strong organizational and documentation skills
- Strong cross‑functional communication skills and ability to operate independently
Preferred Experience and Skills
- Experience launching new products in a high‑growth CPG or wellness brand
- Familiarity with global regulatory requirements (e.g., Health Canada, EU)
- QA certifications (e.g., ASQ Certified Quality Auditor or similar)
- Experience managing and conducting ICH‑guided stability testing for dietary supplements
The anticipated base compensation range for this…
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