O Positiv Health · 5 months ago
Quality & Regulatory Compliance Manager
Santa Monica, California
Full-time
Onsite
Mid, Senior Level
$120K/yr - $140K/yr
5+ years expO Positiv Health is a Los Angeles-based women’s health company dedicated to supporting women through every stage of life with innovative products. They are seeking an experienced Quality & Regulatory Compliance Manager to oversee the quality and compliance of their line of vitamins, supplements, and personal care products, ensuring they meet the highest standards of safety and regulatory compliance.
Dietary SupplementsHealth CareWellness
Responsibilities
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-mans
Review and approve Certificates of Analysis (CoAs), investigating and resolving any out-of-spec results in collaboration with co-mans
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-mans
Serve as primary QA contact for internal cross-functional teams and external co-mans 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 manufacturers 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
Qualification
Required
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 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
Benefits
Flexible PTO, Sick Days, and Wellness Days
Monthly Social Hours
Medical, Vision, and Dental Coverage
401K with matching
$50/month Fitness Reimbursement + Up to $1,800 in annual wellness benefits
Company
O Positiv Health
O Positiv Health is about feeling your best.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Bobby Bitton
CEO & Co-Founder
Brianna Bitton
Co-Founder
Recent News
2026-01-14
2025-11-04
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