Senior Manager, GMP Quality Assurance
Apnimed
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.
Job description
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.
Requirements
- 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
Benefits
- 401(k) Matching
- Generous Vacation Time
- Healthcare Benefits
- Flexible Working Environment
Company overview
Apnimed is a late-stage clinical pharmaceutical company headquartered in Cambridge, Massachusetts, dedicated to the discovery, development, and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases. The company's lead product candidate, AD109, is an investigational first-in-class, fixed-dose oral combination of aroxybutynin (a novel antimuscarinic) and atomoxetine (a selective norepinephrine reuptake inhibitor). AD109 is designed to target the underlying neuromuscular defect of obstructive sleep apnea (OSA) by improving upper airway muscle activity to maintain airway patency during sleep. If approved, it could become the first oral pharmacological treatment for OSA, offering a convenient alternative to masks and devices. Apnimed has completed multiple Phase 3 trials, including LunAIRo and SynAIRgy, both of which met their primary endpoints. The company employs approximately 100 people and is privately held.