Quality Manager, Peptide API & Development
Job Location:
Menlo Park, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Hims & Hers is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable accessible and personal from diagnosis to treatment to delivery. No two people are the same so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions were making better health outcomes easier to achieve.
Hims & Hers is a public company traded on the NYSE under the ticker symbol HIMS. To learn more about the brand and offerings you can visit and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: 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. This role will be responsible for establishing and maintaining a practical inspection-ready quality system that supports peptide API manufacturing laboratory controls and a small GMP-compliant development space for formulation and sterile finished product work intended for transfer into 503A and 503B operations. 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. This leader must be comfortable standing up systems partnering closely with Operations and Technical teams and remaining deeply involved in execution. 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. 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. Bachelors degree or higher in Chemistry Biochemistry Chemical Engineering Pharmaceutical Sciences Microbiology or related field. 610 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. Working Environment Fast-paced startup environment with evolving systems and priorities. Significant interaction with manufacturing laboratory and development teams. Meaningful time spent onsite in production and support areas. May require flexibility in working hours to support startup validation and critical operational activities. 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: ManagerYou Will:
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About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
