Description
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.
Compensation: $175K – $215K
About the Role: 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.
Core Skills & Traits:
- Builder Mindset: Able to create practical systems and standards rather than rely on mature infrastructure.
- Quality Leadership: Capable of setting expectations, holding teams accountable, and building a culture of quality from day one.
- Hands-On Execution: Comfortable reviewing records, resolving issues, and spending time on the floor and in the lab as needed.
- Regulatory Judgment: Able to balance compliance, risk, and business needs while maintaining product quality and patient safety.
- Cross-Functional Collaboration: Works effectively with Operations, Engineering, Technical Development, Supply Chain, and corporate stakeholders.
- Adaptability: Thrives in a fast-paced environment with evolving priorities, limited resources, and a high degree of ownership.
You Will:
- 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, 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 as applicable.
- 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.
- Author, review, and approve SOPs, protocols, reports, specifications, and other GMP documentation required to support manufacturing and development activities.
- 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.
- Support supplier qualification activities and quality oversight of contract laboratories, service providers, and other external partners.
- 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.
You Have:
- 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 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.
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