# Quality Director Peptide API & Development **Company**: Hims & Hers **Location**: Menlo Park, California **Work arrangement**: onsite **Experience**: senior **Job type**: full-time **Salary**: $175K - $215K **Category**: Other **Industry**: Healthcare **Apply**: https://jobs.ashbyhq.com/hims-and-hers/d2cfc29a-6c6e-4cff-a350-dfcdfac0b289?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_5e6d4dc6-22d ## Description We are seeking a hands-on, startup-minded Quality Manager to help build and scale the Quality function for a peptide-focused API manufacturing site with early-phase drug product development capabilities. **Compensation:** $175K – $215K **About the Role:** The ideal candidate brings strong GMP judgment, experience in regulated manufacturing or development environments, and the ability to operate effectively in a build-as-you-go setting. **Core Skills & Traits:** - Builder Mindset: Able to create practical systems and standards rather than rely on mature infrastructure. - Quality Leadership: Capable of setting expectations, holding teams accountable, and building a culture of quality from day one. - Hands-On Execution: Comfortable reviewing records, resolving issues, and spending time on the floor and in the lab as needed. - Regulatory Judgment: Able to balance compliance, risk, and business needs while maintaining product quality and patient safety. - Cross-Functional Collaboration: Works effectively with Operations, Engineering, Technical Development, Supply Chain, and corporate stakeholders. - Adaptability: Thrives in a fast-paced environment with evolving priorities, limited resources, and a high degree of ownership. **You Will:** - Lead development, implementation, and ongoing oversight of the site Quality Management System for peptide API manufacturing and development activities. - Establish and maintain core quality systems, including document control, training, deviations, investigations, CAPA, change control, batch record review, and management review. - Provide Quality oversight for peptide API manufacturing operations, including raw material control, in-process controls, laboratory results review, disposition support, and batch release/rejection decision-making as applicable. - Partner with Operations, Engineering, and Technical teams to support facility scale-up, equipment qualification (IQ/OQ/PQ), process validation, method qualification/validation, and readiness for GMP operations. - Ensure laboratory and analytical activities are performed in a compliant manner, with appropriate controls for methods, specifications, data integrity, and record review. - Support the establishment of a GMP-compliant development environment for early-phase formulation and sterile finished product work intended for future tech transfer to 503A and 503B sites. - Author, review, and approve SOPs, protocols, reports, specifications, and other GMP documentation required to support manufacturing and development activities. - Lead or support investigations related to deviations, OOS/OOT events, complaints, quality events, and associated CAPAs. - Drive inspection readiness and serve as a key Quality lead for regulatory inspections, customer audits, and internal audits. - Establish and monitor quality metrics and trend data to support management review, continuous improvement, and proactive risk management. - Support supplier qualification activities and quality oversight of contract laboratories, service providers, and other external partners. - Recruit, coach, and develop site Quality personnel, including frontline specialists and future QA/QC team members. - Work cross-functionally to ensure tech transfer activities are supported by appropriate documentation, training, comparability assessments, and risk-based Quality oversight. **You Have:** - Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field. - 8+ years of Quality experience in pharmaceutical, biotech, API, sterile manufacturing, or related GMP-regulated environments. - Prior experience building or scaling Quality systems in an early-stage, startup, or rapidly evolving site environment strongly preferred. - Experience with peptide API manufacturing, complex chemical synthesis, sterile manufacturing support, or product development quality oversight is strongly preferred. - Strong working knowledge of cGMP requirements, including relevant expectations under 21 CFR 210/211, ICH Q7, data integrity, and risk-based Quality Systems. - Experience supporting qualification/validation, laboratory controls, investigations, and inspection readiness. - Demonstrated ability to influence cross-functional teams and make sound, timely quality decisions in ambiguous environments. **Benefits:** - Competitive salary & equity compensation for full-time roles - Unlimited PTO, company holidays, and quarterly mental health days - Comprehensive health benefits including medical, dental & vision, and parental leave - Employee Stock Purchase Program (ESPP) - 401k benefits with employer matching contribution - Offsite team retreats ## Skills ### Required - GMP - Quality Management - Regulatory Compliance - Peptide API Manufacturing - Laboratory Controls - Investigations - Inspection Readiness ### Nice to have - complex chemical synthesis - sterile manufacturing support - product development quality oversight --- Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/d2cfc29a-6c6e-4cff-a350-dfcdfac0b289?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)