Senior Director, Quality Systems Medical Device (Hybrid)

Senior Director, Quality Systems Medical Device (Hybrid) page is loaded Senior Director, Quality Systems Medical Device (Hybrid) Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-23010

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 :

Find out if this opportunity is a good fit by reading all of the information that follows below.

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.

Note : The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia and continues to advance clinical and research programs in these diseases.

Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London.

Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook , Twitter / X , LinkedIn , YouTube and Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.

By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear : to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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Remote working / work at home options are available for this role.