Quality Director Peptide API & Development

The role

This role will build and scale the Quality function for a peptide-focused API manufacturing site. The person will establish and maintain a quality system supporting peptide API manufacturing, laboratory controls, and a GMP-compliant development space.

What you will do

• Lead development, implementation, and ongoing oversight of the site Quality Management System
• Establish and maintain core quality systems including document control, training, deviations, and CAPA
• Provide Quality oversight for peptide API manufacturing operations
• Partner with Operations, Engineering, and Technical teams to support facility scale-up and validation
• Ensure laboratory and analytical activities are performed in a compliant manner
• Support the establishment of a GMP-compliant development environment
• Author, review, and approve SOPs, protocols, reports, and specifications
• Lead or support investigations related to deviations, OOS/OOT events, and complaints
• Drive inspection readiness and serve as a key Quality lead for regulatory inspections and audits
• Recruit, coach, and develop site Quality personnel

Required 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
• Strong working knowledge of cGMP requirements, including 21 CFR 210/211 and ICH Q7
• Experience supporting qualification/validation, laboratory controls, investigations, and inspection readiness

Nice to have

• Prior 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

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

About the company

Hims & Hers is a health and wellness platform that provides access to personalized, affordable care. It is a public company traded on the NYSE.