Quality Director Peptide API & Development

hims & hers
Menlo Park
Workplace: OnsiteFull timeUSD 175,000 - 215,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 8+ yearsEducation: bachelorsSkills: ["Builder mindset","Quality leadership","Hands-on execution","Regulatory judgment","Cross-functional collaboration"]

Lead the development, implementation, and oversight of a practical site Quality Management System for peptide API manufacturing and early-phase GMP development. Own core quality processes such as document control, deviations, investigations, CAPA, change control, batch record review, and management review. Partner with Operations, Engineering, and Technical teams to support GMP readiness, qualification/validation activities, laboratory data integrity, tech transfer support, and inspection readiness across internal and external audits.

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FursaFursa
hims & hers
hims & hers
3 days ago

Quality Director Peptide API & Development

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Last checked: 13 hours agoStatus: Live

Job Summary

Lead the development, implementation, and oversight of a practical site Quality Management System for peptide API manufacturing and early-phase GMP development. Own core quality processes such as document control, deviations, investigations, CAPA, change control, batch record review, and management review. Partner with Operations, Engineering, and Technical teams to support GMP readiness, qualification/validation activities, laboratory data integrity, tech transfer support, and inspection readiness across internal and external audits.
Location: Menlo Park
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Director level

Key Responsibilities

  • •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, including raw material control, in-process controls, laboratory results review, and batch release/rejection decision support.
  • •Partner with Operations, Engineering, and Technical teams to support facility scale-up, IQ/OQ/PQ, process validation, method qualification/validation, and readiness for GMP operations.
  • •Drive inspection readiness and serve as a key Quality lead for regulatory inspections, customer audits, and internal audits; also author/review GMP documentation and support supplier qualification and tech transfer readiness.

Pay and Benefits

Salary: USD 175,000 - 215,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVisionPaid LeaveParental Leave401k

Key Requirements

  • •Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or a related field.
  • •8+ years of Quality experience in pharmaceutical, biotech, API, sterile manufacturing, or other GMP-regulated environments.
  • •Strong working knowledge of cGMP requirements, including 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.
  • •Experience building or scaling Quality systems in an early-stage/startup or rapidly evolving site environment (strongly preferred).
Experience:8+ yearsPharmaceuticalBiotechAPI manufacturingSterile manufacturingGMP-regulated environmentsPeptide APIStartup environments
Education:Bachelor's in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field
Skills:Builder mindsetQuality leadershipHands-on executionRegulatory judgmentCross-functional collaboration
Tech Stack:CGMP21 CFR 210/211ICH Q7CAPADeviationsData integrityIQ/OQ/PQBatch record reviewQuality metricsChange control

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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