Senior Manager, Quality Systems and Compliance

Apnimed; Cambridge; Remoto; GBP 126.000 - 141.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) with company match

Generous time off for vacation

Generous healthcare benefits

Flexible working environment

Motivated and experienced team

Best Places to Work (BBJ)

Descrizione del lavoro

Apnimed seeks a Senior Manager, Quality Systems & Compliance to administer and improve the eQMS and related quality processes. You will partner across GxP and corporate quality to ensure compliant, scalable systems as the company moves toward commercialization.

The role requires 8+ years in QA/QMS within pharma/biotech, strong regulatory knowledge, and experience with major eQMS platforms. A remote-friendly, cross-functional environment offers competitive base salary and benefits.

Competenze

• Bachelor's degree or equivalent in a scientific, technical, quality, or related discipline.
• 8+ years of Quality Assurance/Quality Management experience in pharma/biotech
• Experience managing eQMS platforms (Dot Compliance, Veeva Quality, MasterControl, TrackWise Digital, ComplianceWire) and CSV/21 CFR Part 11 concepts.

Mansioni

• Serve as SME and administrator for the eQMS, coordinating testing, validation, and deployment.
• Oversee onboarding and competency requirements for new eQMS admins.
• Maintain system documentation, procedures, validation records, and configuration files.
• Administer training programs and maintain centralized user guidance.
• Provide oversight for document control, deviations, CAPAs, change controls, and audits.
• Manage vendor governance and periodic performance reviews.
• Keep systems inspection-ready and support regulatory inspections and audits.
• Present performance trends and drive cross-functional quality process standardization.

Conoscenze

Quality systems leadership

eQMS administration

Regulatory readiness

Project management

Excellent communication

Analytical skills

Formazione

Bachelor's degree or equivalent in a scientific/technical discipline

Strumenti

Dot Compliance

Veeva Quality

MasterControl

TrackWise Digital

ComplianceWire

Descrizione del lavoro

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 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.

• 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.

• 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.
• 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.