Senior Manager, GMP Quality Assurance

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 is a rapidly growing pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea (OSA) could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., Apnimed is committed to innovation, as well as state‑of‑the‑art advancements in sleep medicine, which is leading to the development of a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Of note, the Boston Business Journal has also voted Apnimed as one of the Best Places to Work in 2024 and 2025!

Summary:

The Senior Manager, GMP Quality Assurance plays a pivotal role in ensuring Apnimed’s products are manufactured, tested, and released in full compliance with global regulatory standards and our internal quality expectations. The role will report to the Associate Director, GMP Quality Assurance. As Apnimed transitions from late‑stage development to commercial readiness, this role provides both strategic oversight and operational execution across all GMP activities, with particular emphasis on external manufacturing and testing partners.

This role supports Apnimed’s mission to deliver transformative therapies for obstructive sleep apnea (OSA) by embedding quality and compliance into every step of the product lifecycle. The Senior Manager serves as a trusted partner to Manufacturing, CMC, Regulatory, and Supply Chain teams, ensuring alignment, transparency, and continuous improvement.

Key Job Duties include, but are not limited to:

• Quality Oversight: Provide day‑to‑day QA support for GMP manufacturing, packaging, and testing activities at CMOs and CROs. Ensure that all operations meet Apnimed’s quality standards and applicable regulatory requirements.
• Documentation Review and Approval: Review and approve master and executed batch records, specifications, protocols/reports, change controls, deviations, and Quality Agreements to ensure accuracy, consistency, and compliance.
• Regulatory and Inspection Readiness: Support NDA‑readiness efforts and maintain inspection‑ready documentation. Participate in internal and external audits and health authority inspections as a QA representative.
• Issue Management and CAPA: Support investigations, perform root cause analyses, and ensure timely and effective CAPA implementation. Track trends and recommend process improvements.
• Quality Systems and Continuous Improvement: Contribute to the enhancement of Apnimed’s Quality Management System (QMS), including policies, procedures, and metrics. Champion quality initiatives that drive efficiency and compliance.
• Cross‑Functional Partnership: Serve as a key QA partner to internal functional teams across CMC, Manufacturing, Supply Chain, Regulatory Affairs, and Technical Operations. Provide guidance on GMP principles and quality risk management.
• Culture and Values: Model and reinforce Apnimed’s Bold, Connected, and Passionate values in all aspects of work—driving collaboration, accountability, and respect across internal and external partners.

Education and Experience:

• Bachelor’s degree in a scientific or technical field.
• Approximately 5-7 years of progressive GMP QA experience in the biotech or pharmaceutical industry, including external manufacturing oversight.
• Deep understanding of GMP regulations (21 CFR Parts 210/211, ICH Q7–Q10, EU Annexes) and their practical application in small‑molecule or combination‑product manufacturing.
• Uses risk‑based thinking to balance compliance, business needs, and patient safety.
• Works effectively across functions, communicates clearly, and builds strong relationships with both internal teams and CMOs/CROs.
• Maintains rigor and precision in document review and data integrity verification.
• Operates with initiative, accountability, and a solutions mindset.
• Seeks ways to strengthen systems, processes, and team performance.
• Demonstrated experience in quality oversight of external manufacturing, validation, and late‑stage CMC activities.
• Ability to manage multiple priorities in a lean, fast‑paced, cross‑functional environment.
• Excellent communication and cross‑functional collaboration skills, ability to influence without authority.
• Willingness to travel occasionally (up to ~15%) for vendor oversight and audits.

What Apnimed Offers:

• 401(k) with company match
• Generous time off for vacation
• Flexible working environment
• Motivated and experienced team
• Winner of 2024 Boston Business Journal Best Places to Work

Location and Other Information:

• Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical.
• We are a small growing Company with an inclusive environment.
• Must be able to travel as necessary.
• Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
• Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.