Director, Global Clinical Quality - Quality Oversight Lead (Remote Eligible)

Vertex Pharmaceuticals-posted 3 days ago

Full-time • Director

Remote • Boston, MA

5,001-10,000 employees

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The Director, Quality Oversight Lead within Global Clinical Quality (GCQ) is responsible for strategic and operational oversight of key activities such as inspection readiness, the GCQ operational framework, continuous improvement initiatives, and expert guidance on computer systems assurance in a clinical trial setting. Additionally, the Director will be responsible for providing quality oversight to Clinical Development and Biometrics functional areas. We seek an individual with strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of inspection readiness principles in a clinical trial setting. This position reports directly to the Senior Director of Global Clinical Quality and will be a key member of the GCQ Leadership Team.

Partner with cross-functional teams to identify and implement measurable and sustainable enhancements in the clinical trial space
Lead a team that is responsible for implementing an effective inspection strategy alongside cross-functional clinical study teams for Vertex submissions globally
Lead a team that provides quality support on computer systems assurance as it relates to GCP and clinical trials
Lead a team that provides quality support to Clinical Development and Biometrics functional areas
Implement and manage the GCQ operational framework including, but not limited to GCQ internal operations (e.g., management of GCQ SOPs and training matrix), GCQ metrics and dashboards (including defining user requirements), and GCQ internal governance.
Promote a culture of continuous improvement and accountability
Responsible for people management including resource forecasting, hiring, employee goal setting, performance management, and career development. May also manage contract staff.
Engages and provides consultation to business partners in advancing proactive and leading quality approaches incorporating best practices and establishing/developing strategies for new models, technologies, and practices across clinical development

B.S. in a scientific or allied health field preferred. Mix of relevant experience and B.S. in other field will be considered.
Typically requires 10+ years of relevant work experience, including experience in a GCP quality role, or relevant comparable background
Requires line management experience or other supervisory work
Excellent understanding of ICH-GCP guidelines, and international clinical trial regulations (e.g., US Title 21 CFR, EU CTR, etc.)
Demonstrated leadership in inspection readiness strategy and planning for clinical trial submission across multiple agencies including, but not limited to FDA, MHRA, and NMPA.
Knowledge and demonstrated experience in application of risk-based quality principles (e.g. QbD) in a pharmaceutical environment
Knowledge and demonstrated experience of providing quality support to Clinical Development and Biometrics functional areas
Excellent understanding of computer systems assurance for clinical trials and related guidelines
Developing individuals and teams; proven leadership capabilities within multi-level organization
Current knowledge of industry trends and best practices - for progressive quality risk management in a regulated environment
Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
Travel required up to 25% to Vertex sites, vendors, investigator sites, etc.

Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.)
Continuous Improvement and Project Management training or certifications

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.
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.

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Director, Global Clinical Quality - Quality Oversight Lead (Remote Eligible)

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