GCP Quality Associate Director

Responsibilities

• Assist in the continuous improvement of the Issue Management process- handling of QEs, trending , and updating processes.
• M anage or assist in (internal and external) GCP Quality Events including, but not limited to investigations, CAPAs, Root Cause Analysis, Effectiveness Checks).
• Perform initial triage of event criticality working with operational Quality , Global Clinical Quality and other Subject Matter Experts, as needed.
• Escalate critical and major finding s to Quality management and monitor key performance indicators.
• Utilize quality tools and techniques to support or perform and document full root cause and investigations, to evaluate and resolve quality issues, and to enhance continuous improvement.
• A ssist in tracking of event completion in expected timeframes and monitor quality of investigation writing.
• C reate investigation and deviation records in the electronic Quality Management System. .
• Communicates proactively with internal and external partners and management.
• Serve as a Subject Matter Expert in the risk-based approach to quality events, and using data to inform trends and next steps in continuous improvement process.
• Generates Metrics / KPIs, Dashboards and Reports, as requested and present results, where needed .
• Participate in inspection readiness and support activities
• May assist with onboarding and ongoing training team members, and may manage direct reports, as needed.
• Assist in additional Quality Assurance initiatives as applicable, including inspection, audit activities
• Assist in Quality Risk Assess ment and Management
• REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• 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 Author ity inspections and audits
• PREFERRED EDUCATION AND EXPERIENCE:
• 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:
• Flex Designation:
• Hybrid-Eligible Or On-Site Eligible
• Flex Eligibility Status:
• In this Hybrid-Eligible role, you can choose to be designated as:
• Hybrid : work remotely up to two days per week; or select
• 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-Hybrid
• Company Information
• Vertex is a global biotechnology company that invests in scientific innovation.

Benefits

Additional Information

Job Description GENERAL POSITION SUMMARY: The Associate Director, GCP Compliance is responsible for the quality assurance and compliance activities in support 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 d emonstrate Vertex Core Values.

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