GCP Quality Associate Director

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 demonstrate Vertex Core Values.

RESPONSIBILITIES:

• Assist in the continuous improvement of the Issue Management process- handling of QEs, trending, and updating processes.

• Manage 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 Qualityand other Subject Matter Experts, as needed.

• 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 and investigations, to evaluate and resolve quality issues, and to enhance continuous improvement.

• Assist in tracking of event completion in expected timeframes and monitor quality of investigation writing.

• Create 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 Assessment 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 Authority inspections and audits

PREFERRED EDUCATION AND EXPERIENCE:

• Bachelor's Degree and 10 years of relevant work experience or a combination of training and experience