Bachelor's degree in a scientific, technical, engineering, quality, or related discipline.
8+ years of experience in Quality Assurance, Quality Systems, or Quality Management in pharmaceuticals or life sciences.
Experience managing electronic Quality Management Systems (eQMS) like Veeva Quality or MasterControl.
Knowledge of FDA, EMA, ICH, GCP, GMP, and GLP regulations.
Experience with regulatory inspections and audits.
Preferred: Direct experience with Veeva Quality and computerized system validation (CSV).
Strong project management and communication skills.
Responsibilities
Serve as the subject matter expert for the electronic Quality Management System (eQMS).
Support integration of new business processes and oversee onboarding for eQMS administrators.
Maintain system documentation, including procedures and validation records.
Administer the training program for quality system responsibilities.
Provide oversight for core quality processes like document control and CAPAs.
Manage vendor governance activities and performance reviews.
Ensure continuous inspection readiness and support regulatory audits.
Present quality system performance trends and collaborate on process standardization.
Benefits
401(k) with company match
Generous time off for vacation
Comprehensive healthcare benefits
Flexible working environment
Collaborative and experienced team
Recognized as a Best Place to Work by Boston Business Journal for 2024 and 2025
Full Job Description
Summary:
The Senior Manager, Quality Systems & Compliance reports to the Senior Director, GCP Quality Assurance and Quality Compliance and is responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, and for keeping them inspection-ready. The successful candidate will also play a key role in strengthening the Quality Management System infrastructure as a business partner across GxP and corporate quality functions, ensuring quality processes remain compliant, scalable, and aligned with the company's transition toward commercialization. This is an exciting opportunity to strengthen the quality infrastructure that supports Apnimed as part of a major paradigm shift in the treatment of sleep apnea from medical devices and surgery to a first in class pharmaceutical treatment.
The expected annual base salary range for this role is $170,000.00 to $190,000.00. Final compensation will depend on the selected candidate's level, education and relevant experience.
Key Job Duties include, but are not limited to:
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and 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: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including 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 and properly documented and filed.
Keep quality systems and records in a state of continuous inspection readiness; support regulatory inspections and audits through preparation of records, reports, metrics, and system demonstrations; and 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.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
8+ years of Quality Assurance, Quality Systems, or Quality Management experience within the pharmaceutical, biotechnology, or life sciences industry, including:
Demonstrated experience managing electronic Quality Management Systems (eQMS), 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/internal audits.
Preferred: Direct administrator experience with Veeva Quality, and experience with computerized system validation (CSV) and 21 CFR Part 11 compliance.
Preferred: Experience supporting both development-stage and commercial pharmaceutical operations, and implementing or enhancing eQMS platforms.
Ability to manage simultaneous priorities and changing deadlines.
Excellent oral and written communication skills.
Strong analytical, organizational, and project management skills.
Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional.
Benefits
401(k) with company match
Generous time off for vacation
Generous healthcare benefits
Flexible working environment
Motivated and experienced team
Winner of 2024 and 2025 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.
Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.
