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Hims & Hers, a NYSE-traded health and wellness platform, is seeking a Quality Director to build and scale the Quality function for a peptide-focused API manufacturing site with early-phase drug product development capabilities. This is a hands-on leadership role responsible for establishing and maintaining a practical, inspection-ready quality system that supports peptide API manufacturing, laboratory controls, and a GMP-compliant development space for formulation and sterile finished product work intended for transfer into 503A and 503B operations.
You will lead development, implementation, and ongoing oversight of the site Quality Management System for peptide API manufacturing and development activities. Core responsibilities include establishing and maintaining quality systems (document control, training, deviations, investigations, CAPA, change control, batch record review, management review), providing Quality oversight for peptide API manufacturing operations (raw material control, in-process controls, laboratory results review, batch release/rejection decisions), and partnering with Operations, Engineering, and Technical teams to support facility scale-up, equipment qualification (IQ/OQ/PQ), process validation, and GMP readiness.
Additional responsibilities include ensuring laboratory and analytical activities are performed in a compliant manner with appropriate controls for methods, specifications, data integrity, and record review; supporting establishment of a GMP-compliant development environment for early-phase formulation and sterile finished product work; authoring, reviewing, and approving SOPs, protocols, reports, specifications, and GMP documentation; leading or supporting investigations related to deviations, OOS/OOT events, complaints, and quality events; driving inspection readiness and serving as a key Quality lead for regulatory inspections, customer audits, and internal audits; establishing and monitoring quality metrics and trend data; supporting supplier qualification and quality oversight of external partners; recruiting, coaching, and developing site Quality personnel; and ensuring tech transfer activities are supported by appropriate documentation, training, and risk-based Quality oversight.
The ideal candidate brings strong GMP judgment, experience in regulated manufacturing or development environments, and the ability to operate effectively in a build-as-you-go setting. You must be comfortable standing up systems, partnering closely with cross-functional teams, and remaining deeply involved in execution. The role operates in a fast-paced startup environment with evolving systems and priorities, requiring significant interaction with manufacturing, laboratory, and development teams, meaningful time spent onsite in production and support areas, and flexibility to support startup, validation, and critical operational activities.
REQUIREMENTS:
- 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
- Prior experience building or scaling Quality systems in an early-stage, startup, or rapidly evolving site environment (strongly preferred)
- Experience with peptide API manufacturing, complex chemical synthesis, sterile manufacturing support, or product development quality oversight (strongly preferred)
- 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
