Senior Director, Device Quality

Vertex Inc.; Boston (MA); Ibrido; USD 214.000 - 320.000; Tempo pieno

Descrizione del lavoro

Vertex Inc. is seeking a Senior Director of Device Quality to provide strategic quality leadership for device and combination product operations across development, manufacturing, testing, clinical, and post-market activities in the Boston area.

You will define and execute the device QA strategy, oversee CDMOs and suppliers, manage design controls, and serve as Management Representative for the Device QMS. In this role, you will ensure ISO 13485, 21 CFR 820, and ISO 14971 compliance, lead CAPA

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Device QA

QMS Oversight

ISO 13485

21 CFR 820

ISO 14971

CAPA

Investigations

Change Control

Regulatory Compliance

Leadership

Cross-functional Leadership

Formazione

Bachelor's degree in a scientific, allied health, or operations research field

Descrizione del lavoro

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.

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

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

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 [e-mail]