hims & hers

2 weeks ago

Quality Manager, Peptide API & Development

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 22 hours agoStatus: Live

Job Summary

Lead development and ongoing oversight of the Quality Management System for a peptide-focused API manufacturing site with early-phase drug product development. Establish GMP-ready quality systems across document control, training, deviations, investigations, CAPA, and batch record review. Provide quality oversight for manufacturing and laboratory controls, support qualification/validation and inspection readiness, and recruit and develop site Quality personnel while partnering cross-functionally to enable future GMP tech transfer.

Location: Menlo Park

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager 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 result review, and disposition support.
•Partner with Operations, Engineering, and Technical teams for facility scale-up readiness, including equipment qualification (IQ/OQ/PQ) and process/method validation.
•Drive inspection readiness and serve as a key Quality lead for regulatory inspections, customer audits, and internal audits; also recruit, coach, and develop Quality personnel.

Pay and Benefits

Salary: USD 130,000 - 155,000 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVisionPaid LeaveParental Leave401kEquity

Key Requirements

•Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related fields.
•6–10+ years of Quality experience in pharmaceutical/biotech/API/sterile 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 early-stage/startup or rapidly evolving environments, with peptide API, complex chemical synthesis, or sterile manufacturing support preferred.

Experience:6+ yearsPharmaceuticalBiotechAPI manufacturingSterile manufacturingGMP-regulated environments

Education:Bachelor's

Skills:Builder mindsetQuality leadershipHands-on executionRegulatory judgmentCross-functional collaboration

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

Glassdoor: 2.9

Website LinkedIn Glassdoor

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hims & hers

2 weeks ago

Quality Manager, Peptide API & Development

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 22 hours agoStatus: Live

Job Summary

Location: Menlo Park

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager 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 result review, and disposition support.
•Partner with Operations, Engineering, and Technical teams for facility scale-up readiness, including equipment qualification (IQ/OQ/PQ) and process/method validation.
•Drive inspection readiness and serve as a key Quality lead for regulatory inspections, customer audits, and internal audits; also recruit, coach, and develop Quality personnel.

Pay and Benefits

Salary: USD 130,000 - 155,000 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVisionPaid LeaveParental Leave401kEquity

Key Requirements

•Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related fields.
•6–10+ years of Quality experience in pharmaceutical/biotech/API/sterile 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 early-stage/startup or rapidly evolving environments, with peptide API, complex chemical synthesis, or sterile manufacturing support preferred.

Experience:6+ yearsPharmaceuticalBiotechAPI manufacturingSterile manufacturingGMP-regulated environments

Education:Bachelor's

Skills:Builder mindsetQuality leadershipHands-on executionRegulatory judgmentCross-functional collaboration

Company Brief

hims & hers

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

Glassdoor: 2.9

Website LinkedIn Glassdoor