Quality Director: Peptide API & Development (Equity)

Socket.dev; Menlo Park (CA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO & holidays

Comprehensive health benefits

401k with employer matching

ESPP

Offsite team retreats

Job summary

Hims & Hers seeks a hands-on Quality Manager to build and scale the Quality function for a peptide API site with early-phase development capabilities. You will establish practical systems, lead QA oversight, and partner with operations, engineering, and development teams onsite to enable GMP readiness and tech transfer.

The role requires strong GMP judgment, execution on the floor and lab, and the ability to drive a culture of quality from day one in a fast-paced startup environment.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 8+ years of Quality experience in pharmaceutical, biotech, API, sterile manufacturing, or related GMP-regulated environments.
• Experience building or scaling Quality systems in early-stage/startup environments preferred.
• Experience with peptide API manufacturing or related quality oversight preferred.
• Strong working knowledge of cGMP requirements, 21 CFR 210/211, ICH Q7, data integrity, and risk-based QMS.

Responsibilities

• Lead development, implementation, and 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: raw material control, in-process controls, laboratory results review, disposition, batch release/rejection decisions.
• Partner with Operations, Engineering, and Technical teams for facility scale-up, IQ/OQ/PQ, process validation, method qualification/validation, readiness for GMP operations.
• Ensure laboratory and analytical activities are compliant, with controls for methods, data integrity, and record review.
• Support GMP development environment for early-phase formulation and sterile finished product work for 503A/503B transfer.
• Author, review, approve SOPs, protocols, reports, specifications, GMP docs.
• Lead or support investigations related to deviations, OOS/OOT, complaints, CAPAs.
• Drive inspection readiness for regulatory/customer/internal audits.
• Establish and monitor quality metrics and trend data for management review and risk management.
• Support supplier qualification and oversight of contract labs and external partners.
• Recruit, coach, and develop site Quality personnel.
• Ensure tech transfer activities are documented and risk-based QA oversight.

Skills

Builder Mindset

Quality Leadership

Hands-On Execution

Regulatory Judgment

Cross-Functional Collaboration

Adaptability

Education

Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field

Job description

Hims & Hers seeks a hands-on Quality Manager to build and scale the Quality function for a peptide API site with early-phase development capabilities. You will establish practical systems, lead QA oversight, and partner with operations, engineering, and development teams onsite to enable GMP readiness and tech transfer.

The role requires strong GMP judgment, execution on the floor and lab, and the ability to drive a culture of quality from day one in a fast-paced startup environment.