Quality Manager, Peptide API & Development

About the role

We are seeking a hands-on, startup-minded Quality Manager to help build and scale the Quality function for a peptide-focused API manufacturing site with early-phase drug product development capabilities.

Responsibilities

• Develop and implement a practical, inspection-ready quality system for peptide API manufacturing, laboratory controls, and a small GMP-compliant development space.
• Oversee the establishment and maintenance of core quality systems, including document control, training, deviations, investigations, CAPA, change control, batch record review, and management review.
• Provide quality oversight for peptide API manufacturing operations, including raw material control, in-process controls, laboratory results review, disposition support, and batch release/rejection decision-making.
• Partner with Operations, Engineering, and Technical teams to support facility scale-up, equipment qualification (IQ/OQ/PQ), process validation, method qualification/validation, and readiness for GMP operations.
• Ensure laboratory and analytical activities are performed in a compliant manner, with appropriate controls for methods, specifications, data integrity, and record review.
• Support the establishment of a GMP-compliant development environment for early-phase formulation and sterile finished product work intended for future tech transfer to 503A and 503B sites.
• Lead or support investigations related to deviations, OOS/OOT events, complaints, quality events, and associated CAPAs.
• Drive inspection readiness and serve as a key Quality lead for regulatory inspections, customer audits, and internal audits.
• Establish and monitor quality metrics and trend data to support management review, continuous improvement, and proactive risk management.
• Recruit, coach, and develop site Quality personnel, including frontline specialists and future QA/QC team members.
• Work cross-functionally to ensure tech transfer activities are supported by appropriate documentation, training, comparability assessments, and risk-based Quality oversight.

Requirements

• Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.
• 6–10+ 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 is strongly preferred.
• Strong working knowledge of cGMP requirements, including relevant expectations under 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.

Qualifications

• Hands-on, startup-minded mindset.
• Strong GMP judgment.
• Ability to set expectations, hold teams accountable, and build a culture of quality from day one.
• Comfortable reviewing records, resolving issues, and spending time on the floor and in the lab as needed.
• Able to balance compliance, risk, and business needs while maintaining product quality and patient safety.
• Works effectively with Operations, Engineering, Technical Development, Supply Chain, and corporate stakeholders.
• Adaptable and thrives in a fast-paced environment with evolving priorities, limited resources, and a high degree of ownership.

Skills

• Builder Mindset
• Quality Leadership
• Hands-On Execution
• Regulatory Judgment
• Cross-Functional Collaboration
• Adaptability

Benefits

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