Senior Director, Quality Assurance

Apnimed; Cambridge (MA); Remote; USD 205,000 - 260,000; Full time

Job summary

A clinical-stage pharmaceutical company in Cambridge seeks a Senior Director of Quality Assurance. This role involves leading a team to ensure compliance with GxP standards, developing quality management systems, and overseeing audits. The ideal candidate has extensive experience in the pharmaceutical industry and strong leadership skills.

Benefits

401(k) with company match

Generous time off for vacation

Flexible working environment

Qualifications

• 20+ years of experience in the pharmaceutical/biotechnology industry.
• 10+ years’ experience in Quality Management.

Responsibilities

• Lead a team of quality professionals and deliver GxP quality guidance.
• Oversee product and clinical trial compliance.
• Manage and improve existing quality systems.

Skills

Leadership

Communication

Risk Assessment

Quality Management

Education

Bachelor’s degree in a scientific discipline

Job description

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Apnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.

Position Overview:

We are seeking an experienced Senior Director, Quality Assurance to lead a team of quality professionals and deliver phase appropriate GxP quality guidance for Apnimed’s investigational programs from early to later phase development and commercialization. This is both a leadership and hands-on role, requiring strategic vision as well as operational execution.

The successful candidate, reporting to the Senior VP of Regulatory Affairs and Quality, will oversee product and clinical trial compliance by managing and improving existing quality systems and ensuring appropriate controls. This includes overseeing the expansion and implementation of a fit for purpose Quality Management System (QMS), development of documents, training of staff, and quality oversight of contract service providers (CSPs). The Senior Director, Quality Assurance shall manage Pre-Approval and Bioresearch Monitoring Program inspection readiness. Knowledge of computerized system validation and Annex 11/Part 11 is critical to success in the role.

Key Job Duties include, but are not limited to:

• Ensure products (be they pharmaceutical, device or other), procedures and practices meet Apnimed’s quality goals and all regulatory standards.
• Serve as a subject matter expert to guide Apnimed on QA related issues by communicating proactively and effectively with appropriate key stakeholders within and external to Apnimed.
• Provide leadership in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company operations, processes and products.
• Facilitate risk-based decision-making, highlighting best practices and approaches while maintaining a consultative and collaborative approach.
• Develop a fit-for-purpose quality management system by directing and providing oversight and input into the relevant quality systems and standards.
• Collaborate with executive and functional leaders to ensure understanding and adherence to company and quality policies, guidelines, programs, and systems.
• Provide oversight and support development of company and departmental SOPs, job descriptions, and training documentation to ensure they are current and relevant.
• Oversee internal and external auditing activities.
• Hire, manage, support and develop/train QA staff and secure sufficient resources to support Apnimed’s goals and objectives.
• Take an active mentorship role in developing the Quality team to best serve the business.
• Direct inspection readiness activities: coordinate activities and lead interactions during regulatory agency inspections of Apnimed facilities and communicate and coordinate with external contractors and vendors regarding regulatory agency inspections for which Apnimed is a Sponsor.
• Ensure appropriate review and approval of Master Batch Records, SOPs, Change Control Documentation, Product Labeling and Revisions, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, and Contractor Qualifications.
• Oversee development and implementation of a GXP training program for relevant Apnimed staff.
• Report on Key Performance Indicators and make improvements and adjustments as indicated by changes in trends.
• Support development and maintenance of operating and capital expense budgets.
• Ensure timelines are met and costs remain within the established budgets.
• Scale up a quality group within the organization to support growth and development needs.

Education and Experience:

• Bachelor’s degree in a scientific discipline
• 20+ years of experience in the pharmaceutical/biotechnology industry
• 10+ years’ experience in Quality Management
• Small company experience is preferred
• Experience with New Drug Applications (NDA) is required
• High level of familiarity with broad range of compliance areas and ability to assess risk and develop solutions
• Deep knowledge of GxP requirements, with an understanding of phase-appropriate clinical and commercial expectations
• Strong proven hands-on experience with a variety of both GMP and GCP compliance matters and contractor management in the bio/pharma industry
• Previous experience with building QA systems and company-wide SOP system
• Experience with regulatory authority inspections and audits
• A proven track record of leadership, people management, and effective interpersonal and communication skills
• Ability to prioritize and manage complex processes/projects
• A “can-do” attitude with a focus on team success, both within Quality and with cross-functional business partners
• Remote position with up to 20% travel

What Apnimed Offers:

• 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 privately held company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical though location in the Northeast is a plus.
• We are a small growing Company with an inclusive environment.
• We are pioneering exciting treatments for sleep apnea and were selected as a member of the 2023 Fierce 15
• 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.
• The estimated salary range for this position is between $205,000 - $260,000. However, final compensation may vary outside of this range based on a candidate’s experience, qualifications, and other relevant factors.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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