Remote Senior Manager, Quality Systems (Pharma)

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

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.