Description

Job Description

General/Position Summary

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.

Key Duties & 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

Required Education Level

• B.S. in a scientific or allied health field preferred. Mix of relevant experience and B.S. in other field will be considered.

Required Experience

• 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

Required Knowledge/Skills

• 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

Other

• 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.

#LI-remote #LI-JS1

Pay Range:
$174,400 - $261,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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.

Flex Designation:
Remote-Eligible

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.

#LI-Remote

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