Assoc. Director, Quality Management Systems

The Associate Director, Quality Management Systems (QMS) is responsible for the site's GxP quality systems, including Document Control, Records Management, and Exceptions Management (Deviations, CAPAs, Change Controls, and Investigations/OOS). Reporting to the Director, Quality Management Systems, this role serves as Business Administrator and subject matter expert for the associated electronic systems, providing first-line user support and ensuring alignment with company policies and regulatory requirements. The Associate Director also identifies improvement opportunities and leads process enhancements.

Success in this role depends on reliable execution, efficient processes, and transparent reporting, both within Quality and to Senior Management.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):          

Under direction from, and in collaboration with the Director, Quality Management Systems, the Associate Director, QMS will:

Systems and Administration

• Contribute to the roadmap and continued maturity of the eQMS, including upgrades and configuration changes.
• Serve as subject matter expert and Business Administrator for the eQMS and eDMS, including user account management, pick list maintenance, and other administrative functions. Verify required training is complete before granting access.
• Provide training and first-line support to system users, and partner with IT to resolve issues and implement enhancements.

Quality Process Oversight

• Administer the deviation, CAPA, investigation, complaint, and change control processes in the eQMS, supporting event owners and tracking progress to meet closure targets.
• Lead weekly meetings to review open quality events and drive timely closure.
• Develop and implement Quality procedures that ensure consistency and compliance.

Training and Awareness

• Promote the requirements and capabilities of the eQMS and eDMS across the organization, and ensure exception owners, reviewers, approvers, document authors, and document reviewers are properly trained and supported.

Metrics and Reporting

• Facilitate Quality Management Review meeting on compliance status.
• Produce, trend, and publish Quality metrics that show performance against requirements, and identify ways to streamline analysis and communication.

Records Management

• Oversee the GxP records lifecycle, including retention, archival, and retrieval of paper and electronic records.

Inspection Readiness

• Participate in inspection readiness activities and provide back-room support during inspections. Serve as subject matter expert for document management and exceptions and interact with regulatory inspectors as needed.

Qualifications and Experience:

• Bachelor's degree (scientific or technical field preferred, or equivalent experience) and 8+ years of experience in Quality Systems within pharmaceutical, biotech, medical device, or another GxP-regulated environment.
• Hands-on experience as a business administrator for an eQMS and an eDMS (document control, deviations, CAPA, change control).
• Experience writing and maintaining Quality procedures.
• Working knowledge of GxP and ICH requirements, including electronic records and signatures (e.g., 21 CFR Part 11), and of exceptions management and records management processes.
• Experience collaborating with IT on system enhancements, upgrades, or validation.
• Experience producing, trending, and presenting quality metrics to senior leadership.
• Experience supporting regulatory inspections or audits, including back-room or SME roles.
• Strong project management, presentation, and facilitation skills, including leading cross-functional meetings.
• Demonstrated ability to influence and drive accountability across teams without direct authority.
• Ability to work independently and within a team structure.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency with Veeva Quality applications (QMS and QualityDocs).
• Proficiency with Microsoft Office, including Excel.