Hims AND Hers

Quality Manager, Peptide API & Development

Menlo Park, California · Full-time

Sponsorship not specifiedDetected 15 days ago

Supply ChainGMPLeadershipCollaborationAdaptability

About the role

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.

Able to create practical systems and standards rather than rely on mature infrastructure.
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.
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.
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.
Recruit, coach, and develop site Quality personnel, including frontline specialists and future QA/QC team members.
No two people are the same, so we provide access to personalized care designed for results.

This leader must be comfortable standing up systems, partnering closely with Operations and Technical teams, and remaining deeply involved in execution.
Adaptability: Thrives in a fast-paced environment with evolving priorities, limited resources, and a high degree of ownership.

Ensure laboratory and analytical activities are performed in a compliant manner, with appropriate controls for methods, specifications, data integrity, and record review.
Author, review, and approve SOPs, protocols, reports, specifications, and other GMP documentation required to support manufacturing and development activities.
Work cross-functionally to ensure tech transfer activities are supported by appropriate documentation, training, comparability assessments, and risk-based Quality oversight.
Bachelor's degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.

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
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.
Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
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.
By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.
For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals.

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.

If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com 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.

This listing is sourced directly from Hims AND Hers's careers page and normalized into a canonical job model.