Senior Director, R&D Vendor Quality Management (Hybrid)

Job Description

The Senior Director, R&D Vendor Quality Management (VQM) is a key leadership role in the Vertex Quality Assurance (QA) organization reporting to the head of Research & Development Quality (RDQ). this role would be directly responsible for leading and building up the RDQ VQM program and will be responsible for working cross-functionally to create a single overall state of vendor quality. In addition, This role will provide strategic direction and oversee the vendor qualification and compliance oversight programs across Research and Development areas ensuring effectiveness of risk management strategies across third parties, affiliates, strategic business partners and internal vendor management. This role requires direct operational experience within GvP, GLP and GCP vendor management and also strong working knowledge of GMP vendor management.

At Vertex, Vendor Quality Management (VQM) has an established Global VQM framework and operating model, while execution of the deliverables of that model are the responsibility of the individual GxP function. These functions include Small Molecule, Drugs and Biologics and Market Quality (GMP); Cell and Gene Therapy (GMP); Research & Development Quality (GvP, GCP and GLP); and Global Quality and Systems Compliance. This role will be responsible for working within the governance model to collaborate and partner within all QA functions to create an overall state of vendor quality across all GxPs leveraging the current VQM teams. In addition, this role will directly lead a team within RDQ and be responsible for further establishing a scalable and continuously improving fit-for purpose and phase appropriate vendor management oversight program.

Key Duties and Responsibilities:

• Provides strategic leadership and oversight up the RDQ VQM program and would take over leadership of the PON and be responsible for uniting all VQM outputs to work with cross-functional leaders to create a single overall state of vendor quality
• Provides strategic direction and oversight to development, execution, and continual improvement of vendor quality risk management/mitigation strategies.
• Drives and oversees the development of risk-informed vendor-related quality standards establishing fit-for-purpose expectations for selection, oversight, and governance of the organization's GxP suppliers and vendors across product modalities
• Collaborates with quality and business leadership to align on vendor performance and risk indicators and other relevant data that permit comprehensive vendor assessment and decision-making about needed actions.
• Provides insights on the state of global vendor risks at Vertex based on review of data and trends.
• Sits as an ambassador and active contributor to RDQ leadership and strategy as a member of the RDQ Leadership Team.
• Direct oversight and involvement regarding R&D specific vendor quality events and issue management and operational and QA-QA leadership meetings.
• Strong understanding and ability to implement risk management fundamentals/tools, especially as it relates to vendor management.
• Provides insights about vendor risk that inform audit planning, inspection readiness, and governance strategies employed by quality counterparts in audit and inspection management and operations.
• Provides subject matter expertise as the quality system owner for vendor management during the planning, conduct, and response to inspections.
• Design program-specific quality strategy and partner with business stakeholders across R&D stakeholders for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness
• Provides leadership to implementation of risk-based approaches to quality for clinical development program(s) - e.g. Quality by Design principles, risk-based quality management (RBQM) and ensures effectiveness of mechanisms for ongoing quality risk monitoring, mitigation and management
• Provides strategic oversight and ensures development, implementation and maintenance of the program quality plan summarizing the result of evidence of quality activities
• Leads and/or provides strategic direction/oversight to program-focused quality working groups to define integrated quality plans/activities
• Serves as an escalation point of contact or Quality representative and leader to cross-functional clinical development teams, therapeutic area Leadership and quality governance bodies as applicable
• Manages, or collaborates when applicable, for-cause, critical and/or complex quality issues for program areas
• Responsible for the seamless integration and smooth transition of newly acquired or onboarded business partners and affiliates ensuring their programs are appropriately assimilated into the Vertex Portfolio and part of the Vertex governance infrastructure.
• Strategic leadership of proactive inspection readiness strategies and review at key project milestones in support of organizational deliverables and decision-making models
• Oversees the RDQ risk assessment profile across the Quality Management System with the objective of ensuring transparency for gaining insights regarding state of compliance and adherence with quality standards/requirements across operational and Quality areas providing strategic input to improvement initiatives for advancing operational excellence in quality.
• Partners with other Quality Management area heads to ensure alignment of strategic and operational goals with priorities of the business and QA for delivery of results necessary
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Contemporary understanding of global regulations and ICH guidance; direct Regulatory Authority experience or significant track record of interaction with health authorities across multiple regions.
• QA experience in a Sponsor company or organization; or Contract Organization (CxO) with 10 years QA leadership experience spanning Quality operations (e.g., audit, compliance, inspection, operational quality management).
• Highly collaborative and skilled at establishing effective working relationships with cross-functional groups and reaching common understanding on quality issues.
• Comfortable working in a demanding fast-paced, patient-focused organization, with start-up culture and evolving processes. Flexible and able to adapt to new situations as the business demands.
• Excellent verbal, written and presentation communication skills are essential.
• Experienced in pre-clinical, clinical, and chemical, manufacturing and controls (CMC) processes with demonstrated knowledge and application of quality and risk management approaches across GxP areas.
• A "doer" and individual willing to "roll up their sleeves" is key; flexibility to adapt to a start-up environment is required.
• Operational Excellence experience with proven ability to lead improvement projects
• Experience with Root Cause analysis best practices and principles
• Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.
• Ability to travel up to 15%.

• Other Requirements
• Proven ability to manage projects/team of significant scope and complexity, while meeting all deliverables and timelines
• Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GxP vendor practices
• Displays highly effective coaching and people management abilities as well as a successful track record of developing junior staff
• Strong analytical skills and comprehensive understanding of the basic quality toolbox (root cause analysis, inspection standards, basic statistics, etc.)
• Excellent interpersonal skills. Ability to lead global quality improvement efforts and drive harmonized, fit for purpose approaches across GxP areas.
• Strong understanding and ability to implement risk management fundamentals/tools, especially as it relates to vendor management.
• Thorough knowledge of global regulatory requirements (FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities)

Education and Experience:

• M.S (or equivalent degree) and 10 +years of relevant work experience, B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background
• Typically requires 15+ years of relevant experience in a pharmaceutical, medical device or biologics company, and 10 years of supervisory/management experience, or the equivalent combination of education and experience.

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

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.

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