Director GCP Quality Details

Director GCP Quality

Vertex Pharmaceuticals - Boston, MA

Employment Type : Full-Time

Job Description

The Director GCP Quality provides leadership in assuring appropriate quality/compliance oversight of Vertex's clinical trial-related processes, initiatives, and systems. The role will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs.

The Director GCP Quality will actively partner across R&D Quality and Global Clinical Operations and act as a catalyst for continuous improvement. This role will ensure clinical trial-related processes, initiatives, and systems account for evolving R&D-related regulations and inspection trends and maintain currency with external best practices, as appropriate.

The Director GCP Quality will ensure communication and visibility of meaningful indicators of process health to permit ongoing identification of operational risks in core clinical trial processes that will require action. This individual will ensure delivery of both portfolio and program-level views of clinical process and quality system risk and performance to relevant stakeholders across R&D Quality and the business.

The Director GCP Quality will report to the Sr. Director, Medical and Clinical Operational Quality, and will work closely with other R&D Quality members to drive scalable, phase appropriate clinical-trial related processes and ensure consistency in execution across development programs.

RESPONSIBILITIES:

Broad responsibilities include:

OPERATIONS MANAGEMENT : Oversees and ensures effectiveness of clinical trial-related processes and ongoing inspection readiness

ALIGNMENT : Engages the organization through direct line-of-sight of their work to Vertex's vision 2030 and cross-QA operational performance in delivery of strategic and business goals/objectives

EXECUTION : Actively champions and technically guides quality and relevant business areas to drive real-time inspection readiness in core clinical trial related processes and activities

ROLE MODELLING: Consistently demonstrates an ongoing commitment to achievement of Vertex and QA goals, as well as the success of all team members consistent with the Vertex phenotype

Specific responsibilities include .

• Partners with functional areas within the Global Clinical Operations (GCO) organization and with other internal stakeholders in Quality to ensure appropriate quality/compliance oversight of Vertex's clinical trial-related processes and systems and solution partnering.

• Provides expertise and consultative guidance on business initiatives involving processes, procedures, regulations, and tools intended for use in clinical trial conduct.

• Identifies and anticipates potential compliance issues that may impact the ability to meet business goals; develops and implements methods of improvement and resolution in a pragmatic and effective manner.

• Maintains ongoing inspection readiness for processes that support clinical trial planning and execution, including conducting periodic spot checks of process adherence and documentation (e.g. TMF reviews).

• Serves in an advisory/ consultative role in development of audit strategy for clinical trial-related processes.

• Partners with clinical operations and quality to define and establish robust clinical trial quality performance metrics (e.g. KQIs) across clinical trial operations and delivery.

• Ensures timely and effective communication of summary trending and other insights on the quality of delivery in clinical trials to relevant business and quality partners and in relevant forums (e.g. Integrated Risk Governance Teams).

• Supports the delivery of operational governance meetings (e.g. QLT)

• Supports continuous improvement of quality processes that assure compliance of clinical studies conducted by Vertex and its partners with global regulatory expectations.

• Assures effective and appropriate identification, remediation, and escalation of quality issues related to Vertex clinical trial processes.

• Maintains current awareness of global regulatory requirements and monitors for changes in regulatory interpretation relevant to Vertex’s clinical trial processes.

• Leads or participates in strategic initiatives to improve compliance to regulatory requirements and standards related to clinical trial conduct

• Participates in external initiatives and industry forums related to clinical trials and translates insights to R&D Quality and its clinical operations partners.

• Participates in Due Diligence and integration activities as appropriate

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES

Key Leadership Skills:

• Learn, Teach, Develop

• Lead by example

• Foster exemptional collaboration

• Drive breakthrough results

• Promote enterprise thinking

Key Technical Knowledge, Skills and Competencies:

• Broad and deep global health regulatory agency knowledge and practical experience interpreting and applying regulations related to research and development areas

• Current knowledge of industry trends and best practices for efficiency, compliance and effectiveness related to clinical trial process design and delivery

• Broad and deep operational and project management knowledge and experience

• Demonstrated strategic planning and execution skills required

• Proven ability to design/evolve and /or implement processes and KPIs that are fit-for-purpose manner enabling effectiveness and assessment of process performance

• Developing individuals and teams; proven leadership capabilities within multi-level organization

• Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness

• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence

• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions

PREFERRED EDUCATION AND EXPERIENCE:

• B.S./M.S. in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background

• Professional association membership and participation preferred, not required (for example: RAPS, DIA, SQA, RQA)

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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.