Senior Director, Quality Systems/QMS

Senior Director, Global Quality Systems

The Senior Director, Global Quality Systems holds a pivotal leadership position within the Quality organization. This individual is 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. The role is instrumental in promoting leading practices and supporting the organization's growth as well as adapting to industry changes.

This leader provides strategic leadership and oversight across all aspects of Global Quality Systems. This includes guaranteeing the integrity and effectiveness of the framework, enhancing capabilities, and ensuring robust execution throughout GxP domains, various products, modalities, and geographies within the Quality Management System. This position reports to the Vice President of Global Quality Systems and Compliance and serves on major quality and compliance leadership teams.

The ideal candidate will possess senior-level leadership skills, extensive regulatory compliance expertise, and robust GxP operational/Quality oversight experience in this highly visible role. This individual will have a proven record of excellent stakeholder management/ability to influence with strong capability for enterprise thinking in fully aligning stakeholders to achieve optimal standardization and harmonization while ensuring fit-for-purpose applications that enhance agility, efficiency, and effectiveness throughout the global QMS.

Key Responsibilities:

• Quality Management System Leadership:
• 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 effective fit for purpose implementation for optimizing outcomes in enabling business objectives
• Ensures systematic identification, assessment and control of QMS-level risks, drives a culture of quality by design and continuous improvement, and ensures lessons learned are translated 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)
• Quality Systems Oversight and Strategic Direction:
• Owner and champion across the QMS the overall Quality Systems Ownership model implementation and governance for ensuring system health and effectiveness and integration across QMS and operational governance
• Leads team of Quality Systems Owners (QSOs), each with accountability for the health and effectiveness of a defined cross-QMS-level Quality System, e.g., Quality Risk Management, Vendor Quality Management, Event Management, and Knowledge Management, Data Integrity
• Leads/chairs integrated Quality Systems oversight and governance (e.g., PONs, other QS-specific governance and interfaces with operational governance across the QMS (e.g., QMR)
• Through cross-QS strategic oversight, ensures alignment of internal and external (outsourced/third party) QS standards, expectations and internal governance to ensure global oversight, transparency and continual improvement across the Vertex QMS
• Quality Leadership, Enterprise Partnership, Change Management and Quality Culture Championship:
• Role models Quality Leadership, serving as a visible leader, advocating quality culture, and ensuring accountability, transparency, and integrity in how quality decisions are made and communicated across the enterprise
• Partners with QA leadership and enable enterprise functions (e.g., Finance, Strategic Sourcing, Human Resources) in proactive management and strategic planning and translation into operating standards, inspection readiness, compliance and excellence
• Lead, develop, and mentor quality professionals to mature the capabilities and leadership needed to scale and transform the organization and QMS across a diverse portfolio of products, technologies, geographies, and evolving business needs. Serve as change agent for transformation initiatives, including digitization and advanced technology integration across the QMS

Minimum Qualifications:

Required:

BS, MS, JD, MD, or PhD in a Life Sciences discipline or equivalent. Fifteen (15) years relevant work experience with 7 years 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 preferred.

Experience building sustainable and advanced oversight programs/Quality Systems/QMS models and governance for ensure compliance across GxP areas and products/programs.

In-depth knowledge in the following areas:

• 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 organization 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 able to adapt as business needs change.
• Excellent verbal, written, and presentation skills are essential.
• 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 the 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%.