Quality Manager (GMP)

TL;DR

Quality Manager (GMP): Build and scale a practical, inspection-ready Quality Management System for peptide API manufacturing and early-phase drug product development with an accent on cGMP compliance, inspection readiness, and hands-on execution across lab and production. Focus on establishing core quality processes (document control, deviations, investigations, CAPA, change control, batch record review) and partnering with Operations and Technical teams to qualify equipment, validate methods, and support tech transfer to 503A/503B operations.

Company

hirify.global is a health and wellness platform focused on delivering personalized access to care.

What you will do

• 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, and management review.
• Provide Quality oversight for peptide API manufacturing, including raw material control, in-process controls, laboratory results review, and batch release/rejection decisions.
• Partner with Operations, Engineering, and Technical teams for facility scale-up, equipment qualification (IQ/OQ/PQ), process validation, and method qualification/validation for GMP readiness.
• Ensure laboratory and analytical activities are compliant with controls for methods, specifications, data integrity, and record review.
• Drive inspection readiness and support regulatory inspections, customer audits, and internal audits; manage quality metrics and trend data for continuous improvement and proactive risk management.

Requirements

• Location: On-site in Menlo Park, California
• Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or a related field.
• 6–10+ years of Quality experience in pharmaceutical/biotech/API/sterile manufacturing or other GMP-regulated environments.
• 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, build-as-you-go environments.

Culture & Benefits

• Fast-paced startup environment with evolving systems and priorities.
• Significant time spent onsite in production and support areas, including lab and floor work as needed.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits (medical, dental, vision) plus parental leave; ESPP and 401k with employer matching.
• Offsite team retreats and a Total Rewards package that may include equity.