Quality & Regulatory Compliance Manager

Quality & Regulatory Compliance Manager

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, and OPositiv.com. 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. Our team combines an entrepreneurial spirit with a passion for innovation and a commitment to impact. Join us, and you'll have the opportunity to grow alongside a company that's making a real difference.

Your Role

We'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.

This is not a traditional in-plant QA role. All of our products are manufactured by third-party partners, so the ideal candidate will bring strong experience in quality oversight for co-manufactured products, ideally in the vitamins and supplements space.

Responsibilities and 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-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

Qualifications and Skills

• Experience:
• 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
• Interpersonal:
• Meticulous attention to detail, with strong organizational and documentation skills
• Strong cross-functional communication skills and ability to operate independently

• Additional 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

Hours and Compensation

The anticipated base compensation range for this role will be $120,000 - $140,000. Compensation will be commensurate with the candidate's experience and local market rates.

• Job Type: Full-time
• Pay based on prior experience
• Position will be based out of Santa Monica, Los Angeles - in person (Mon-Thurs in office/Friday remote)

Benefits & Perks

• 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
• An environment of collaboration, high performance, and respect amongst all employees