Quality Manager, Peptide API & Development

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, we’re 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 company’s outstanding benefits, culture, and its talent‑first flexible/remote work approach, see below and visit

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…