Senior GMP QA Manager: External Manufacturing & Compliance

Apnimed; Cambridge (MA); Remote; USD 170,000 - 210,000; Full time

Benefits offered by this job

401(k) with company match

Generous vacation time

Flexible working environment

Best Places to Work 2024/2025

Job summary

Apnimed, based in Cambridge, MA, is seeking a Senior Manager, GMP Quality Assurance to lead quality oversight across external manufacturing and testing partners as we move toward commercial readiness. The role reports to the Associate Director, GMP QA and collaborates with Manufacturing, CMC, Regulatory, and Supply Chain to ensure compliant documentation and CAPA processes.

The position emphasizes QA leadership, regulatory readiness, and continuous improvement while supporting NDA submissions

Qualifications

• Bachelor’s degree in a scientific or technical field.
• 5–7 years of GMP QA experience with external manufacturing oversight.
• Deep understanding of GMP regulations (21 CFR Parts 210/211, ICH Q7–Q10, EU Annexes).
• Uses risk-based thinking to balance compliance, business needs, and patient safety.

Responsibilities

• Provide day-to-day QA support for GMP manufacturing, packaging, and testing at CMOs/CROs.
• Review and approve master and executed batch records, specifications, protocols/reports, change controls, deviations, and Quality Agreements to ensure accuracy, consistency, and compliance.
• Support NDA-readiness efforts and maintain inspection-ready documentation. Participate in internal and external audits and health authority inspections as a QA representative.
• Investigate issues, perform root cause analyses, and ensure timely and effective CAPA implementation.
• Contribute to the enhancement of Apnimed’s Quality Management System (QMS) and drive continuous improvement.

Skills

GMP QA experience

External manufacturing oversight

Regulatory knowledge

Cross-functional collaboration

Documentation review

Data integrity verification

Education

Bachelor’s degree in a scientific or technical field

Job description

Apnimed, based in Cambridge, MA, is seeking a Senior Manager, GMP Quality Assurance to lead quality oversight across external manufacturing and testing partners as we move toward commercial readiness. The role reports to the Associate Director, GMP QA and collaborates with Manufacturing, CMC, Regulatory, and Supply Chain to ensure compliant documentation and CAPA processes.

The position emphasizes QA leadership, regulatory readiness, and continuous improvement while supporting NDA submissions