Hims & Hers
Quality Director Peptide API & Development
$175K–$215K
Menlo Park, California · On-site · Director · Full-time · Posted Sep 15, 2026
- Experience
- 8+ years of Quality experience in pharmaceutical, biotech, API, sterile manufacturing, or related GMP-regulated environments.
- Education
- Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.
About the job
Build and lead an inspection-ready Quality function and quality systems for peptide API manufacturing and early-phase drug product development.
What you'll do
- Establish and oversee the site Quality Management System, including documentation, training, investigations, CAPA, change control, and batch record review.
- Provide Quality oversight for manufacturing, laboratory controls, validation, development, tech transfer, and batch disposition.
- Lead inspection readiness, audits, quality metrics, supplier oversight, and development of site Quality staff.
What they ask for
- Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or a related field.
- Strong working knowledge of cGMP requirements, including 21 CFR 210/211, ICH Q7, data integrity, and risk-based Quality Systems.
- Experience supporting qualification/validation, laboratory controls, investigations, and inspection readiness.
- Demonstrated ability to influence cross-functional teams and make sound, timely quality decisions in ambiguous environments.
Nice to have
- Experience building or scaling Quality systems in an early-stage, startup, or rapidly evolving site environment.
- Experience with peptide API manufacturing, complex chemical synthesis, sterile manufacturing support, or product development quality oversight.
Pay
$175K – $215K (base salary)
Tools
21 CFR 210/211, ICH Q7, IQ/OQ/PQ, CAPA, cGMP
Model-written summary · the original posting is authoritative