Vertex ยท 3 weeks ago
Director, Global Clinical Quality - Quality Oversight Lead (Remote Eligible)
United States
Full-time
Remote
Director/Executive
$174K/yr - $262K/yr
10+ years expVertex is a global biotechnology company that invests in scientific innovation. The Director, Quality Oversight Lead within Global Clinical Quality is responsible for strategic and operational oversight of key activities such as inspection readiness and quality support in clinical trials. This role involves leading a team to implement effective inspection strategies and promote continuous improvement in the clinical trial space.
Computer Software
Responsibilities
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
Qualification
Required
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
Preferred
Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.)
Continuous Improvement and Project Management training or certifications
Travel required up to 25% to Vertex sites, vendors, investigator sites, etc
Benefits
Medical, dental and vision benefits
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)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase