GCP Quality Associate Director

General Position Summary

The Associate Director, GCP Compliance is responsible for the quality assurance and compliance activities in support of Quality Issues Management and other activities within RDQ. This role will support GCP related events and escalation of these events to Senior Management and other key stakeholders. This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organization and will demonstrate Vertex Core Values.

• Assist in the continuous improvement of the Issue Management process, including handling of QEs, trending, and updating processes.
• Manage or assist in (internal and external) GCP Quality Events, including investigations, CAPAs, root cause analysis, and effectiveness checks.
• Perform initial triage of event criticality in collaboration with operational Quality, Global Clinical Quality, and other subject matter experts.
• Escalate critical and major findings to Quality management and monitor key performance indicators.
• Utilize quality tools and techniques to support or perform and document full root cause investigations, evaluate and resolve quality issues, and enhance continuous improvement.
• Track event completion in expected time frames and monitor quality of investigation writing.
• Create investigation and deviation records in the electronic Quality Management System.
• Communicate proactively with internal and external partners and management.
• Serve as a subject‑matter expert in the risk‑based approach to quality events, using data to inform trends and next steps in the continuous improvement process.
• Generate metrics, KPIs, dashboards and reports as requested and present results when needed.
• Participate in inspection readiness and support activities.
• Assist with onboarding and ongoing training of team members, and may manage direct reports as needed.
• Assist in additional Quality Assurance initiatives, including inspection and audit activities.
• Assist in Quality Risk Assessment and Management.

• Experience successfully leading event investigations, root cause analysis, and CAPAs.
• Knowledge of current industry trends and ability to use the latest technologies.
• Highly organized with strong planning capabilities.
• Compliance and GCP quality management experience.
• Strong communication, problem‑solving, and critical‑thinking skills.
• Knowledge of overall issue management processes, risk‑based approaches, and best practices.
• Experience in quality analytics and using data to make decisions and identify trends.
• Experience in Health Authority inspections and audits.

Bachelor’s Degree and 10 years of relevant work experience, or a combination of training and experience.

Pay Range: $160,600 - $240,800. 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.

Benefits include medical, dental, and vision coverage; generous paid time off; a company shutdown in the summer and winter; educational assistance programs; student loan repayment; a commuting subsidy; charitable donation matching; 401(k); and more.

Hybrid‑Eligible: you can choose to work remotely up to two days per week or on‑site all five days, with ad hoc flexibility.

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 should make a request to the recruiter or hiring manager, or contact Talent Acquisition at A