Senior Director, Quality Systems Medical Device (Hybrid)

Job Description

General Summary :

The Senior Director, Device Quality Systems owns the strategic direction, design and execution of the Device Quality Management System (QMS).

This role uses superior risk management expertise and quality management tools to maximize value and positively impact the development of device and combination products for Vertex while assuring compliance, quality excellence and readiness for all future device and combination product needs.

The role will work with QA management and business partners to define organizational strategies, operating plans and associated budgets, and annual goals / objectives and priorities, partnering across QA and other stakeholders as needed to ensure alignment of strategic and operational goals with business priorities.

Key Duties and Responsibilities :

• Define strategy, implement and own a Vertex Device Quality Management System that is suitable for current and future device needs.
• Provides leadership and partners with QA management in proactive and strategic planning for device needs using risk management techniques to t ranslate strategy into standard operating procedures and plans for execution
• Partners with stakeholders across enabling functions (e.g. BSMO, R&D etc) for alignment of strategies, and optimization of programs for delivery.
• Resource management including enhanced planning, prioritization, resourcing strategies and projection of future needs and capabilities
• Partners with QA leadership and managers for determination of needs for tools, metrics, mechanisms .
• Monitors the external environment for leading practices, emerging trends and projection of future industry and QA capabilities requirements and uses research findings to recommend approaches that will improve performance or efficiency, reduce costs, or increase ROI.
• Tracks and reports on operating results to ensure consistent progress toward achieving organizational goals.
• Leads and develops direct reports for excellence in delivery and effective outcomes
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills :

• Demonstrated broad expertise in strategic planning, budget management, operational planning, and operational excellence in a dynamic and evolving business model.
• Proven leadership capabilities within multi-level organization, including strong staff development and mentoring
• Strong change management experience, adaptability, and resourcefulness
• Excellent oral and written communication skills to negotiate internally / externally
• A proven track record in building and leveraging collaborative relationships to drive results.
• Strong business acumen, problem-solving and decision-making skills, utilizing a solutions-driven approach and demonstrating an appropriate level of judgment
• Ability to achieve results through communication, facilitation, negotiations in a cross-functional environment with shared responsibilities
• Demonstrated knowledge of applicable global, regional and local regulatory requirements applicable to organization activities

Education and Experience :

• Bachelors degree in a scientific, allied health, or operations research field
• Typically requires 12 years of relevant work experience and 5 years of supervisory / management experience or the equivalent combination of education and experience

Flex Designation :

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status :

In this Hybrid-Eligible role, you can choose to be designated as :

1. Hybrid : work remotely up to two days per week; or select

2. On-Site : work five days per week on-site with ad hoc flexibility.