Job Description

General Summary:

The Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.

The role is accountable for risk-based operational Quality oversight of internal activities and external partners, including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global device and combination product requirements.

The Senior Director serves as the Management Representative for the Device QMS, providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives.

Key Duties and Responsibilities:

•        Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.

•        Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.

•        Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.

•        Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.

•        Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.

•        Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.

•        Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.

•        Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.

•        Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.

•        Build organizational capability through talent development, coaching, and strong cross-functional leadership.

Knowledge and Skills:

•        Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.

•        Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.

•        Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.

•        Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.

•        Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.

•        Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.

•        Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.

•        Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.

•        Demonstrated leadership in cross-functional strategic initiatives.

•        Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.

Education and Experience:

• Bachelors degree in a scientific, allied health, or operations research field
• Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience

#LI-Hybrid

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

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.

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

#LI-Hybrid
 

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 ApplicationAssistance@vrtx.com