Quality & Regulatory Compliance Manager

Who We Are

O Positiv Health is a Los Angeles-based womens health company on a mission to support women through every stage of lifefrom their first period to well beyond their last. Since launching in 2018 O Positiv has reshaped the womens 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 supportoffering vitamins supplements and personal care products that women trust.

Today O Positiv products are sold nationwide at Target Walmart CVS Amazon TikTok Shop and . Were 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 womens health. Our team combines an entrepreneurial spirit with a passion for innovation and a commitment to impact. Join us and youll have the opportunity to grow alongside a company thats making a real difference.

Your Role

Were 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 $120000 - $140000 annually. Compensation will be commensurate with the candidates 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 $1800 in annual wellness benefits
• An environment of collaboration high performance & respect amongst all employees and

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O Positiv is proud to be an equal opportunity employer and does not discriminate on the basis of race national origin gender gender identity sexual orientation protected veteran status disability age or other legally protected status.

O Positiv believes in the power of building a diverse and culturally inclusive team. We seek candidates from all backgrounds to join our teams. Were driven to build a workplace based on inclusive behaviors and equitable systems where all employees can bring their authentic selves feel engaged and share their perspectives as a valued member of O Positiv.