GCP Quality Associate Director

GENERAL POSITION SUMMARY:

The Associate Director GCPComplianceis responsible forthe quality assurance and compliance activities insupportQuality Issues Management and other activities within RDQ. This rolewillsupportGCP related events and escalation of these eventsto 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 willdemonstrateVertex Core Values.

RESPONSIBILITIES:

• Assistin the continuous improvement of the Issue Management process- handling of QEstrendingand updating processes.

• Manage orassistin (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 findingsto Quality management andmonitorkey performance indicators.

• Utilize quality tools andtechniquestosupport or perform and document full root causeandinvestigations to evaluate and resolve quality issues and to enhance continuous improvement.

• Assistintracking ofevent completion in expectedtimeframesandmonitorquality of investigation writing.

• Create investigation and deviation records inthe electronic QualityManagementSystem..

• Communicates proactively with internal and external partners and management.

• Serve as a Subject MatterExpert in the risk-based approach to qualityevents andusing data to inform trends and next steps incontinuousimprovement process.

• Generates Metrics / KPIs Dashboards and Reports as requestedand presentresults whereneeded.

• Participate in inspection readiness and support activities

• Mayassistwith onboarding and ongoing training team members and may manage direct reports as needed.

• AssistinadditionalQuality Assurance initiatives as applicable including inspection audit activities

• Assistin 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 problemsolvingand critical thinking skills

• Knowledge of overall issue management processesrisk-basedapproaches and best practices

• Experience in quality analytics and using data to make decisions andidentifytrends

• Experience inHealth Authorityinspections and audits

PREFERRED EDUCATION AND EXPERIENCE:

• Bachelors Degree and 10 years of relevant work experience or a combination of training and experience