Senior Manager, Quality Systems and Compliance

Apnimed•Cambridge, MA

1d•$170,000 - $190,000•Remote

About The Position

Apnimed is a pharmaceutical company developing oral pharmacologic treatments for obstructive sleep apnea and related disorders. The Senior Manager, Quality Systems and Compliance reports to the Senior Director, GCP Quality Assurance and Quality Compliance. This role administers, maintains, and continually improves Apnimed’s electronic Quality Management System (eQMS) and related quality processes, keeping them inspection-ready. The position also strengthens quality-system infrastructure across GxP and corporate quality functions so processes remain compliant, scalable, and aligned with the company’s transition toward commercialization. The role serves as the eQMS subject matter expert and administrator, supporting system changes, testing, validation, deployment, documentation, user training, and support. It provides oversight for core quality processes and vendor governance, supports audits and regulatory inspections, analyzes system performance, and works across departments to standardize and improve quality processes. The position may require travel as necessary. Apnimed is generally virtual, and the specific location within the United States is not critical.

Requirements

Bachelor’s degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
At least 8 years of Quality Assurance, Quality Systems, or Quality Management experience in the pharmaceutical, biotechnology, or life sciences industry.
Demonstrated experience managing electronic Quality Management Systems, including administering or supporting platforms such as Dot Compliance, Veeva Quality, MasterControl, TrackWise Digital, ComplianceWire, or similar.
Working knowledge of FDA, EMA, ICH, GCP, GMP, and GLP requirements.
Experience supporting regulatory inspections and external or internal audits.
Ability to manage simultaneous priorities and changing deadlines.
Excellent oral and written communication skills.
Strong analytical, organizational, and project management skills.
Proficiency in MS Word and PowerPoint; experience with Adobe Acrobat Professional.

Nice To Haves

Direct administrator experience with Veeva Quality.
Experience with computerized system validation (CSV) and 21 CFR Part 11 compliance.
Experience supporting both development-stage and commercial pharmaceutical operations.
Experience implementing or enhancing eQMS platforms.

Responsibilities

Serve as subject matter expert and administrator for the eQMS; evaluate proposed system changes and coordinate testing, validation, and deployment.
Support integration of new business processes, departments, and vendors into the Quality Management System.
Oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program, including assignment and curriculum alignment, role-based eQMS training, user support, and a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Manage vendor governance activities and periodic performance reviews, ensuring reviews are completed, documented, and filed.
Maintain quality systems and records in a state of continuous inspection readiness.
Support regulatory inspections and audits by preparing records, reports, metrics, and system demonstrations; monitor industry trends and regulatory expectations.
Present quality-system performance trends and recommendations to Quality leadership.
Lead or support continuous improvement initiatives and collaborate cross-functionally to standardize quality processes across departments.