Job DescriptionGeneral 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 leadershipKnowledge 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
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Pay Range:$213,600 - $320,400
Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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 select2.
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.
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