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. This role will be responsible for establishing and maintaining a practical, inspection-ready quality system that supports peptide API manufacturing, laboratory controls, and a small GMP-compliant development space for formulation and sterile finished product work intended for transfer into 503A and 503B operations.
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. This leader must be comfortable standing up systems, partnering closely with Operations and Technical teams, and remaining deeply involved in execution.
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.
Working Environment- Fast-paced startup environment with evolving systems and priorities.
- Significant interaction with manufacturing, laboratory, and development teams.
- Meaningful time spent onsite in production and support areas.
- May require flexibility in working hours to support startup, validation, and critical operational activities.
Our Benefits (there are more but here are some highlights):- 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
