General Description:

The Senior Director, Digital Quality Management Systems (QMS) Strategy and Operations, leads the digitalization of the QMS and supports QMS users. This role is responsible for the electronic enterprise Quality applications, ensuring their continuous evolution to meet patient and business needs. Additionally, the role ensures these systems comply with applicable regulations.

Essential Functions of the job:

• Develop and oversee the Digital QMS governance model and roadmap to support activities across all product lifecycle phases, ensuring alignment with business needs and the Quality Strategy.

• Act as the system owner for all digital GxP enterprise Quality applications.

• Maintain the Digital QMS in compliance with current regulatory standards while meeting the company’s quality and business objectives.

• Lead electronic system implementations and enhancement projects in collaboration with Business Process Owners and IT.

• Define and maintain a digital quality systems onboarding and training strategy.

• Provide comprehensive oversight of Digital Quality Systems, ensuring effective management, operations, and user adoption.

• Ensure appropriate data quality for systems owned.

• Leverage Artificial Intelligence (AI) capabilities to enhance the company’s digital QMS.

• Develop and maintain business administration processes for Digital Quality Systems.

• Ensure Digital Quality applications are inspection-ready and serve as a Subject Matter Expert (SME) during Health Authority inspections.

• Lead and develop a team of QMS Business Analysts, QMS Project Managers and QMS Operations.

• Act as Quality Lead for cross-functional digital GxP application projects.

• Manage business relationships with suppliers of digital quality applications.

• Promote a strong quality culture, ensuring that digital application implementation and usage are fit for purpose and upholding the highest levels of data integrity and compliance.

• Support the Global Quality leadership team in driving key Quality Culture initiatives.

• Perform other responsibilities as assigned.

Supervisory Responsibilities:

• Ensure leadership, guidance and development opportunities for direct reports

Skills and Qualifications:

• Bachelors degree with 12+ years, Masters with 8+ years, or PhD/PharmD/MD with 6+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global environment required.

• Advanced degree in life sciences, computer sciences, quality management, or related field preferred.

• In-depth operational experience in at least one area of the GxP product life cycle, allowing solid understanding of business needs for digital quality applications

• Advanced knowledge of US, EU, ICH and other GxP regulations

• Experience in managing and operating digital quality applications (Veeva preferred)

• Strong leadership, project management, and stakeholder management skills

• Ability to communicate complex information clearly and effectively across business functions

Travel: up to 20% internationally

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.