Quality Leader for Peptide API & Development

hims & hers; Menlo Park (CA); On-site; USD 160,000 - 210,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO and holidays

Comprehensive health benefits

ESPP

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers is building a Quality function for a peptide API manufacturing site, focusing on establishing practical, inspection-ready systems and ensuring product quality and patient safety. The role emphasizes hands-on leadership, collaboration with Operations and Technical teams, and regulatory readiness for GMP operations.

The ideal candidate will bring deep GMP experience, a builder mindset, and a track record of implementing quality systems in early-stage or rapidly evolving settings,

Qualifications

• Bachelor's degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.
• 8+ years of Quality experience in pharmaceutical, biotech, API, sterile manufacturing, or related GMP-regulated environments.
• Experience building or scaling Quality systems in a startup or rapidly evolving site environment preferred.
• Experience with peptide API manufacturing, complex chemical synthesis, sterile manufacturing support, or product development quality oversight favored.
• Strong working knowledge of cGMP requirements, including 21 CFR 210/211, ICH Q7, data integrity, and risk-based Quality Systems.

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: document control, training, deviations, investigations, CAPA, change control, batch record review, management review.
• Provide Quality oversight for peptide API manufacturing operations, including raw material control, in-process controls, lab results review, disposition support, and batch release/rejection decisions.

Skills

Builder Mindset

Quality Leadership

Hands-On Execution

Regulatory Judgment

Cross-Functional Collaboration

Adaptability

Education

Bachelor's degree or higher

Job description

Hims & Hers is building a Quality function for a peptide API manufacturing site, focusing on establishing practical, inspection-ready systems and ensuring product quality and patient safety. The role emphasizes hands-on leadership, collaboration with Operations and Technical teams, and regulatory readiness for GMP operations.

The ideal candidate will bring deep GMP experience, a builder mindset, and a track record of implementing quality systems in early-stage or rapidly evolving settings,