Quality Director: Peptide API & Development

Hims, Inc.

Menlo Park (CA)

On-site

USD 170,000 - 230,000

Full time

11 days ago

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Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Health benefits

ESPP

401k

Offsite retreats

Job summary

Hims & Hers is seeking a hands‑on Quality Manager to build and scale the Quality function for a peptide API manufacturing site with early‑phase development capabilities. You will establish an inspection‑ready quality system and partner with Operations and Technical teams to enable GMP operations.

You will lead document control, deviations, CAPAs, change control, and batch release decisions while driving readiness for regulatory inspections.

Qualifications

8+ years of Quality experience in GMP environments.
Startup or rapidly evolving site experience preferred.
Experience with peptide API manufacturing or sterile manufacturing is preferred.
Strong working knowledge of cGMP, 21 CFR 210/211, ICH Q7, data integrity.
Ability to influence cross-functional teams and make timely decisions.

Responsibilities

Lead development and oversight of the site Quality Management System for peptide API manufacturing and development.
Establish core quality systems: document control, training, deviations, investigations, CAPA, change control, batch review, management review.
Provide Quality oversight for manufacturing operations and batch release decisions as applicable.
Partner with Operations, Engineering, and Technical teams to support scale‑up and validation activities.
Ensure laboratory controls, data integrity, and compliant documentation.
Support GMP‑compliant development environment for early‑phase formulation and tech transfer readiness.
Author and approve GMP documentation: SOPs, protocols, reports, specifications.
Lead investigations related to deviations, OOS/OOT, complaints, and CAPAs.