Quality & Regulatory Compliance Manager

OverviewO 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, TikTok 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. 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 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. 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.ResponsibilitiesLead all QA activities across our contract manufacturing network, ensuring full compliance with relevant regulatory standardsDevelop, implement, and maintain a robust Quality Management System (QMS) tailored to the needs of the businessLead 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-mansReview and approve Certificates of Analysis (CoAs), investigating and resolving any out-of-spec results in collaboration with co-mansManage third-party labs and testing facilities for microbiological, stability, and compatibility testingInvestigate and resolve quality issues, including product non-conformance, consumer complaints, and manufacturing deviationsDevelop, maintain, and enforce quality agreements and SOPs with all co-mansServe as primary QA contact for internal cross-functional teams and external co-mans on all product quality or compliance issuesStay current on evolving supplement regulations and proactively adjust internal processes to remain in complianceSupport documentation and regulatory submissions for new market launchesEvaluate and qualify new manufacturers partners in collaboration with Operations and R&D, including supplier qualification evaluations, risk assessments, and review of quality measuresReview, 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 readinessQualifications and SkillsExperience:5+ years of experience in Quality Assurance and Regulatory Compliance, with a focus on dietary supplementsDeep familiarity with FDA 21 CFR Part 11, and cGMP regulations and third-party certification standardsExperience managing contract manufacturing partners, inspections, and regulatory readinessStrong understanding of formulation, product stability, ingredient sourcing, and supplement production processes and regulatory requirementsInterpersonal:Meticulous attention to detail, with strong organizational and documentation skillsStrong cross-functional communication skills and ability to operate independentlyAdditional Preferred Experience and Skills:Experience launching new products in a high-growth CPG or wellness brandFamiliarity 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 supplementsHours and CompensationThe 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-timePay based on prior experiencePosition will be based out of Santa Monica, Los Angeles - in person (Mon-Thurs in office/Friday remote)Flexible PTO, Sick Days, and Wellness DaysMonthly Social HoursMedical, Vision, and Dental Coverage401K with matching$50/month Fitness Reimbursement + Up to $1,800 in annual wellness benefitsAn environment of collaboration, high performance, and respect amongst all employees and managersApplicant Privacy PolicyO 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. We’re 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.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionOtherIndustriesManufacturing, Retail Health and Personal Care Products, and Personal Care Product ManufacturingInferred from the description for this jobMedical insuranceVision insurance401(k)Paid maternity leavePaid paternity leave #J-18808-Ljbffr

Created: 2025-10-08