Director, R&D Quality Risk Management and Patient Centricity Operations (Remote)

Job Description

The Director, R&D Quality Risk Management and Patient Centricity Operations, is responsible for defining and operationalizing the R&D Quality Management System (QMS) and advancing "One State of Quality" across the R&D organization. This role leads quality governance and risk management efforts, supports operations related to patient centricity and ethics, and fosters a culture of quality in collaboration with cross-functional stakeholders. The role ensures alignment between risk-based decision-making, operational excellence, and a patient-centered approach within R&D Quality.

Key Responsibilities:

• Define and implement the R&D Quality Management System (QMS) framework, aligning with enterprise systems and regulatory expectations.
• Lead the development and execution of the "One State of Quality" initiative, including authorship and maintenance of the R&D Quality Standard document.
• Facilitate cross-functional quality governance within R&D, enabling consistent visibility into quality performance, risk mitigation, and decision-making.
• Lead facilitation of quality risk assessments across R&D Quality, using standardized methodologies and collaborating with business partners for ongoing risk monitoring.
• Collaborate with the R&D Analytics & Centers of Excellence (ACE) team to evaluate data trends, identify emerging risks, and inform quality improvement opportunities.
• Serve as the centralized coordinator in R&D Quality for the Process Owner Network (PON), partnering closely with Global Quality Systems PON Leads to ensure R&D PON members align processes, metrics, and analytics with global Quality System standards but with a lens to R&D, including research, pre-clinical, clinical, and pharmacovigilance quality.
• Coordinate the R&D Quality Champions network, driving execution of quality responsibilities across functional teams and serving as a liaison to business leadership.
• Support operations and alignment of patient centricity and ethics activities across R&D Quality, ensuring these principles are embedded into quality frameworks and risk management practices.
• Promote a culture of quality and patient focus across R&D through strategic engagement, communication, and collaboration with internal stakeholders.
• Lead tracking of departmental goals and performance metrics, including responsibility for reporting, dashboarding, and progress updates.
• Support budget planning and execution for R&D Quality initiatives, including resource prioritization aligned with strategic and operational goals.
• Contribute to broader R&D Quality leadership initiatives, representing the function in strategic planning forums and operational working groups.

Qualifications & Experience

• 10+ years of experience in R&D Quality, Quality Systems, Risk Management, or related functions within the pharmaceutical/biotech industry.
• Strong knowledge of GxP regulations, quality governance, risk assessment methodologies, and systems development.
• Experience working in or supporting patient centricity or clinical trial participant engagement initiatives.
• Proven success in implementing governance structures, quality improvement programs, and collaborative networks.
• Skilled in data analytics, performance metrics, and trend evaluation in partnership with analytics teams.
• Effective communicator with a demonstrated ability to influence, align, and partner across a matrixed environment.
• Experience managing goals tracking and department-level budget execution preferred.
• Demonstrated leadership in operationalizing strategic objectives within complex organizations.

#LI-AR1 #LI-Remote

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. 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 ApplicationAssistance@vrtx.com