GMP QA & Compliance Leader (Director)

Climb Bio; Wellesley (MA); On-site; USD 158,000 - 230,000; Full time

Benefits offered by this job

Discretionary annual bonus

Medical, Dental, Vision

Disability insurance

Life insurance

401k match

Paid time off

Stock options

Job summary

Climb Bio, a clinical-stage biotechnology company in Wellesley, MA, seeks an Associate Director/Director, GMP QA & Compliance to lead quality operations and oversee global clinical supply through regulatory submission readiness.

Reporting to the VP, Head of Quality, you will build and develop the GMP QA program, manage DS/DP/IP labeling, coordinate with EU/ex-US Qualified Person, and partner with CMC, Regulatory Affairs, and external providers to ensure compliant, scalable quality systems for

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline.
• 8–14+ years GMP quality assurance experience in biotech or pharma; Phase 3 and/or commercial experience preferred.
• Working knowledge of FDA and international GMP regulations, including IND/BLA submission support.
• Demonstrated people leadership with ability to lead in a lean organization; build structure and resourcing.

Responsibilities

• Serve as GMP Quality leader for DS/DP/IP activities and build GMP QA capability.
• Partner with CMC on transfer, validation, and scale-up activities.
• Advise on GMP requirements, risk assessments, and quality decisions; influence outcomes with external partners.
• Own DS/DP/IP labeling review and disposition for global clinical supply across regions.
• Coordinate EU/ex-US certification and release with the Qualified Person for global distribution.
• Ensure 21 CFR 820 compliance for combination products; utilize consultants as needed.
• Contribute to CMC content and quality sections of regulatory submissions.
• Own GMP inspection readiness and host regulatory inspections.
• Design and improve GMP QA program for Phase 3 and commercialization.
• Develop and deliver GMP training; author SOPs and quality agreements.

Skills

People leadership

Regulatory knowledge

Problem solving

Communication

Travel ability

Education

Bachelor's degree

Job description

Climb Bio, a clinical-stage biotechnology company in Wellesley, MA, seeks an Associate Director/Director, GMP QA & Compliance to lead quality operations and oversee global clinical supply through regulatory submission readiness.

Reporting to the VP, Head of Quality, you will build and develop the GMP QA program, manage DS/DP/IP labeling, coordinate with EU/ex-US Qualified Person, and partner with CMC, Regulatory Affairs, and external providers to ensure compliant, scalable quality systems for