Director, Quality Systems

What You’ll Do:

The Senior Director, Quality Systems is a high-impact leadership role responsible for the architecture, implementation, and continuous improvement of our Enterprise Quality Management System (eQMS). You will report to the Vice President, Quality and will serve as the primary architect of our quality framework, ensuring our global operations remain compliant with GxP standards while maintaining the agility required of a growing biotech.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities:

• Define and execute the long-term vision for the Quality Management System (QMS) to support global clinical development and future commercialization
• Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals
• Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules including Document Control, Training, Deviations, CAPA, and Change Control
• Establish and lead Quality Management Reviews (QMR). Develop and report on Key Quality Indicators (KQIs) and metrics to senior leadership to drive proactive risk management
• Ensure the QMS meets global regulatory requirements (FDA 21 CFR Parts 11, 210, 211, and 820; ICH E6; EudraLex Volume 4)
• Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory inspections (FDA, EMA, etc.) and oversee the internal and vendor audit programs
• Champion a culture of Quality. Streamline complex workflows to reduce cycle times for document approvals and deviation closures without compromising compliance
• Build and mentor a high-performing team of Quality professionals, fostering a collaborative environment that balances technical rigor with pragmatic problem-solving

 

Required Qualifications:

• 12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, with at least 5 years in a senior leadership capacity
• Direct experience implementing or managing Veeva QualityVault is mandatory. You should be proficient in configuring workflows and leveraging the platform for data-driven decision-making
• Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies
• Deep knowledge of global GxP regulations and experience participating in (or leading) successful regulatory inspections
• Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders

 

Education:

• Bachelor’s degree required, scientific or engineering discipline preferred
• Advanced degree preferred