Senior Director, Quality Systems/QMS

About the Role

The Senior Director, Global Quality Systems holds a pivotal leadership position within the Quality organization, responsible for providing strategic vision and direction to advance the framework, strengthen organizational capabilities, and ensure the sustainability and effectiveness of the Quality Management System. This role promotes leading practices, supports organizational growth, and adapts to industry changes. The leader provides strategic oversight across all aspects of Global Quality Systems, ensuring integrity and effectiveness within GxP domains, various products, modalities, and geographies. This position reports to the Vice President of Global Quality Systems and Compliance and serves on major quality and compliance leadership teams.

Responsibilities

• Provides strategic leadership and oversight to ensure Quality Systems health, integrity, and effectiveness throughout GxP domains, products, modalities, and geographies across the global Quality Management System.
• Ensures QS alignment with global regulatory expectations through global quality standards and fit-for-purpose implementation to optimize business objectives.
• Ensures systematic identification, assessment, and control of QMS-level risks, drives a culture of quality by design and continuous improvement, and translates lessons learned into systemic improvements.
• Owns the overall QSO/Quality Systems model and strategic roadmap for evolution, ensuring readiness and sustainability for emerging and future changes (e.g., scaling, digital enablement, and readiness for emerging technologies and novel modalities).
• Owns and champions the Quality Systems Ownership model implementation and governance to ensure system health, effectiveness, and integration across QMS and operational governance.
• Leads a team of Quality Systems Owners (QSOs), each accountable for the health and effectiveness of defined cross-QMS-level Quality Systems (e.g., Quality Risk Management, Vendor Quality Management, Event Management, Knowledge Management, Data Integrity).
• Leads and chairs integrated Quality Systems oversight and governance (e.g., PONs, QS-specific governance) and interfaces with operational governance across the QMS (e.g., QMR).
• Ensures alignment of internal and external (outsourced/third-party) QS standards, expectations, and governance for global oversight, transparency, and continual improvement.
• Role models Quality Leadership, advocating for a quality culture, and ensuring accountability, transparency, and integrity in quality decisions across the enterprise.
• Partners with QA leadership and enterprise functions (e.g., Finance, Strategic Sourcing, Human Resources) in proactive management, strategic planning, and translation into operating standards, inspection readiness, compliance, and excellence.
• Leads, develops, and mentors quality professionals to mature capabilities and leadership needed to scale and transform the organization and QMS across a diverse portfolio of products, technologies, geographies, and evolving business needs.
• Serves as a change agent for transformation initiatives, including digitization and advanced technology integration across the QMS.

Requirements

• BS, MS, JD, MD, or PhD in a Life Sciences discipline or equivalent.
• Fifteen (15) years of relevant work experience with 7 years in a leadership supervisory role in a global organization.
• Operational/Quality oversight experience (GMP and/or GCP with additional breadth preferred).
• Experience working across operational functions and at an enterprise level.
• Experience building sustainable and advanced oversight programs/Quality Systems/QMS models and governance to ensure compliance across GxP areas and products/programs.

Qualifications

• Contemporary understanding of global regulations and ICH guidance, with direct regulatory authority experience or a strong track record of interactions with health authorities across multiple regions.
• QA experience in a sponsor or contract organization, with at least 10 years of QA leadership across quality operations such as audit, compliance, inspection, and operational quality management.
• Highly collaborative and effective at building strong enterprise and cross-functional relationships; a strategic change leader who delivers results through influence, partnership, and leadership.
• Comfortable in a demanding, fast-paced, patient-focused environment with a start-up culture and evolving processes; flexible and adaptable to changing business needs.
• Excellent verbal, written, and presentation skills.
• Experience across preclinical, clinical, and CMC processes, with demonstrated application of quality and risk management principles across GxP areas.
• Hands-on, action-oriented leader willing to roll up their sleeves, with flexibility to adapt to a start-up environment.
• Operational excellence experience, including leading improvement projects and applying root cause analysis and methodologies such as Lean, DMAIC, and Six Sigma.
• Strong problem-solving, critical-thinking, and data analysis skills to support sound decision-making.
• Ability to travel up to 15%.

Pay

The pay range for this role is $213,600 - $320,400. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

• Inclusive market-leading medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan.

Schedule

This is a Hybrid-Eligible role, allowing you to work remotely up to two days per week or choose to work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.