Director, Device Operational QA

Vertex Pharmaceuticals Inc (US); Boston (MA); In loco; USD 185.000 - 277.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work arrangement

Annual bonus and equity awards

Descrizione del lavoro

Vertex Pharmaceuticals Inc. seeks a Director of Device Operational QA to lead and develop the device QA team, ensuring strong quality-system execution and cross-functional collaboration. The role partners with senior Quality leadership on strategic initiatives and risk management.

The position requires deep expertise in device QA, regulatory requirements, and quality improvements, with at least 12+ years of experience and 5+ years in management. Onsite presence in Boston is expected.

Competenze

• Typically requires 12+ years of relevant work experience and 5 years of supervisory/management experience
• Significant progressive experience in quality assurance, quality systems, or related regulated environment
• Demonstrated experience supporting design control and risk management for medical devices and combination products
• Demonstrated people-management experience including coaching and talent development
• Minimum bachelor’s degree in a scientific, engineering, allied health, or related field; advanced degree preferred

Mansioni

• Lead and develop the Device Operational QA team with clear priorities and performance expectations
• Provide quality oversight for device operational activities and ensure compliant quality-system processes
• Serve as a quality partner to cross-functional teams supporting device programs and operations
• Lead assessment, resolution, and escalation of complex operational quality issues and risks
• Oversee quality events, deviations, investigations, CAPA, and change controls
• Review and approve device-related design controls and risk management documentation
• Monitor quality performance, trends, and emerging risks; report to leadership
• Maintain audit and inspection readiness for device operations
• Drive continual improvement of QA processes, tools, and ways of working
• Promote risk-based decision-making and a culture of quality across device operations
• Contribute to quality strategy and capability-building with senior leadership
• Ensure timely execution of quality commitments and actions

Conoscenze

Device Operational QA

Quality-system principles

Regulatory & ISO knowledge

Quality risk management

Quality-event management

Audit readiness

Leadership & people management

Cross-functional collaboration

Decision-making & accountability

Communication skills

Formazione

Bachelor’s degree in science/engineering/related field

Advanced degree preferred

Descrizione del lavoro

Job Description General Summary: The Director, Device Operational QA, is responsible for leading operational quality assurance activities supporting device programs and operations within Quality. This people-management role provides oversight of device quality-system execution, promotes consistent application of quality standards, and serves as a key quality partner to cross-functional stakeholders. The Director leads and develops the Device Operational QA team, manages quality matters and risks, and drives effective, sustainable quality improvements. The role translates functional quality priorities into operational execution while partnering with senior Quality leadership on strategic initiatives, significant quality risks, and organizational priorities. This role requires a minimum of 3 days onsite per week at our Boston, MA office.

Key Duties and Responsibilities

• Lead, coach, and develop the Device Operational QA team; establish clear priorities, performance expectations, and development plans.
• Provide quality oversight for device operational activities and ensure consistent execution of applicable quality-system processes and standards.
• Serve as a key quality partner to cross-functional teams supporting device programs and operations.
• Lead assessment, resolution, communication, and escalation of complex operational quality issues and risks.
• Ensure appropriate oversight of quality events, including deviations, nonconformances, investigations, corrective and preventive actions, and change controls, as applicable.
• Provide directions for the review and approval of device-related quality documentation and records that include design controls and risk management, at a minimum.
• Monitor operational quality performance, metrics, trends, and emerging risks; communicate findings and recommendations to Quality leadership and key stakeholders.
• Support and maintain audit and inspection readiness for device operational activities.
• Drive continual improvement of Device Operational QA processes, procedures, tools, and ways of working.
• Promote risk-based decision-making, accountability, collaboration, and a culture of quality across device operations.
• Contribute to functional planning, quality strategy, and capability-building initiatives in partnership with senior Quality leadership.
• Ensure timely execution of quality commitments and appropriate follow-up on actions, decisions, and escalated matters.

Knowledge and Skills

• Strong knowledge of Device Operational QA and quality-system principles.
• Knowledge of applicable regulatory and ISO related requirements for operational quality oversight.
• Knowledge of quality risk management and risk-based decision-making.
• Knowledge of quality-event management, including deviations, nonconformances, investigations, CAPA, and change control.
• Knowledge of quality documentation, record review, and approval practices.
• Knowledge of audit and inspection readiness activities.
• Ability to lead, develop, and motivate teams within a quality organization.
• Ability to assess complex quality matters, identify risks and trends, and appropriately elevate issues.
• Strong cross-functional collaboration, stakeholder management, and influencing skills.
• Ability to prioritize competing demands and drive execution in a complex operational environment.
• Strong written, verbal, presentation, and interpersonal communication skills.
• Demonstrated commitment to quality, compliance, continuous improvement, accountability, and sound judgment.

Education and Experience

• Typically requires 12+ years of relevant work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience
• Significant progressive experience in quality assurance, quality systems, operational quality, manufacturing quality, or a related regulated environment.
• Demonstrated experience supporting design control and risk management activities for medical devices and combination products.
• Demonstrated people-management experience, including coaching, performance management, talent development, and team leadership.
• Minimum bachelor’s degree in a scientific, engineering, allied health, or related field; advanced degree preferred.

#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

$184,600 - $277,000

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.

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 [e-mail].

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. 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 IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.