**General Description:** The Director, QMS Project and Portfolio Management, is responsible for driving the strategic execution and oversight of the Quality Management System (QMS) portfolio, ensuring alignment with organizational priorities and regulatory requirements. This role involves developing and managing the QMS strategy, fostering stakeholder alignment, acting as a liaison with Quality Excellence (QEx) initiatives, and overseeing global risk escalation processes. Additionally, the role ensures effective communication and governance for QMS-related projects and initiatives at a global level. + Lead the development and execution of the QMS strategy to ensure alignment with organizational objectives and industry best practices. + Identify and prioritize key QMS projects and initiatives to enhance quality performance and compliance. + Ensure the QMS evolves to meet emerging regulatory requirements and business needs. + Collaborate with cross-functional stakeholders to align QMS initiatives with broader organizational goals. + Facilitate regular engagement with senior leadership, site quality teams, and other key stakeholders to drive QMS improvements. + Act as the central point of contact for QMS-related discussions across departments. + Serve as the liaison between the QMS team and Quality Excellence (QEx) initiatives, ensuring alignment and integration of quality improvement programs. + Support the implementation of global quality initiatives and harmonization projects. + Oversee the portfolio of QMS projects, ensuring effective planning, execution, and monitoring of initiatives. + Develop and maintain project management tools and processes to track progress, manage risks, and allocate resources. Provide regular updates to leadership on the status of QMS portfolio activities. + Manage global risk escalation processes for critical quality issues and QMS-related risks. + Collaborate with stakeholders to assess, prioritize, and address escalated risks. + Ensure timely and effective communication of risk mitigation plans and outcomes to senior leadership. + Develop and implement a robust communication strategy for QMS initiatives and updates. + Ensure clear, consistent, and timely communication of QMS priorities, progress, and outcomes to global stakeholders. + Create and distribute reports, presentations, and updates to promote transparency and alignment. + Perform other responsibilities as assigned. **Supervisory Responsibilities:** + NA **Skills and Qualifications:** + Advanced degree in life sciences, quality management, or related field + 10+ years of experience in quality systems, project management, or portfolio management within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). + Strong understanding of quality systems, regulatory requirements (e.g., FDA, EMA), and QMS best practices. + Proficiency in project and portfolio management tools and methodologies. + Exceptional communication, facilitation, and collaboration skills. + Ability to manage complex projects and navigate ambiguity in a global matrix environment. **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.