Sr. Manager Quality Systems – Pharma Career at Apnimed

Apnimed; Cambridge (MA); Remote; USD 170,000 - 190,000; Full time

Job summary

Apnimed, a growing Cambridge, MA-based pharma company, seeks a Sr. Manager of Quality Systems & Compliance to lead the eQMS and related QA processes as the company commercializes its sleep apnea program.

This role offers remote work with US-wide flexibility and high visibility to senior leadership. The successful candidate will own the eQMS infrastructure, ensure inspection readiness, and partner across GxP and corporate quality functions to scale quality for commercialization.

Qualifications

• Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
• 8+ years of Quality Assurance, Quality Systems, or Quality Management in pharma/biotech/life sciences.
• Experience administering or supporting eQMS 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 audits.
• Preferred: direct Veeva Quality admin experience; CSV and 21 CFR Part 11 experience.

Responsibilities

• Serve as SME and administrator for the electronic Quality Management System (eQMS), evaluating changes and coordinating testing/validation.
• Oversee onboarding, training, and competency requirements for new eQMS admins; integrate new processes and vendors.
• Maintain system documentation including procedures, validation documents, and configuration records.
• Administer training programs; manage role-based eQMS training and user support; maintain guidance and FAQs.
• Provide oversight for core quality processes: document control, deviations, CAPAs, change controls, investigations, supplier quality, and training management.
• Manage vendor governance activities and periodic performance reviews with proper documentation.
• Keep systems inspection-ready; support regulatory inspections with records, reports, metrics, and demos.
• Present system performance trends to leadership and drive cross-functional process standardization.

Skills

Veeva Quality

eQMS administration

Part 11 compliance

GxP compliance

Regulatory inspections

CSV knowledge

Education

Bachelor's degree in science/engineering/quality

Tools

Dot Compliance

Veeva Quality

MasterControl

TrackWise Digital

ComplianceWire

Job description

Sr. Manager Quality Systems – Pharma Career at Apnimed — Remote

This Senior Manager role sits at a high-impact inflection point for Apnimed — the company is transitioning from development-stage to commercialization, meaning the eQMS infrastructure you build now will directly shape how the company scales. That's a rare and career-defining opportunity in pharma quality.

Compensation benchmark: The $170K–$190K range is competitive for a Senior Manager in pharma QA/quality systems in the US. Comparable roles at mid-size biotech typically range $155K–$200K, so this sits solidly in the upper-mid tier — especially strong given the fully remote flexibility.

Skills you'll develop and market value:

• Deep Veeva Quality / eQMS platform expertise — highly transferable across all major pharma and biotech companies
• 21 CFR Part 11 and CSV proficiency — in strong demand as more companies digitize quality systems
• GxP compliance across GCP/GMP/GLP — breadth that opens doors to Director-level QA roles
• Pre-commercial to commercial transition experience — a resume credential that commands premium compensation

Green flags: Two-time Boston Business Journal "Best Places to Work" winner, explicit mention of inclusivity, small team culture with real ownership, and a first-in-class drug program that could yield an FDA approval milestone on your watch.

Potential consideration: As a small, growing company, processes may still be maturing — ideal if you thrive in building from scratch, but potentially challenging if you prefer well-established systems. The role reports directly to a Senior Director, offering strong visibility to leadership.

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. 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.

Recognized by the Boston Business Journal as one of the Best Places to Work in both 2024 and 2025, we are continuing to grow and build the foundational operations that enable our employees and our mission to thrive.

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 overview 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 results 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.
• 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 MS Word and PowerPoint; experience with Adobe Acrobat Professional.
• 401(k) with company match
• Generous time off for vacation
• 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.
• 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.

Is this role fully remote or is there an office requirement? Apnimed describes itself as "generally virtual" and states that a specific location within the US is not critical. However, candidates must be US-based and willing to travel as necessary for audits, inspections, or team meetings. What is the salary range for the Senior Manager, Quality Systems & Compliance role? The expected annual base salary range is $170,000 to $190,000. Final compensation depends on the selected candidate's level, education, and relevant experience. What eQMS platforms are relevant for this role? The job listing mentions platforms including Dot Compliance, Veeva Quality, MasterControl, TrackWise Digital, and ComplianceWire. Direct Veeva Quality administrator experience is specifically preferred. How much experience is required to apply? Candidates need 8+ years of Quality Assurance, Quality Systems, or Quality Management experience within the pharmaceutical, biotechnology, or life sciences industry, along with demonstrated eQMS administration experience. What regulatory frameworks should candidates be familiar with? Candidates should have working knowledge of FDA, EMA, ICH, GCP, GMP, and GLP requirements, as well as experience supporting regulatory inspections. Familiarity with 21 CFR Part 11 and computerized system validation (CSV) is preferred.