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Quality Assurance Technician
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Associate Director Quality Assurance - York, North Yorkshire, United Kingdom - Pivot Search
Description
Associate Director Quality AssuranceSUMMARY:
The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations.
This leader collaborates closely with the Clinical Trials Leadership team to achieve outcomes that not only meet but exceed client expectations.
Setup:
Hybrid North Yorkshire (2-3 days onsite/week)
Requirements:
Bachelor's Degree (required)Master's Degree (preferred)7+ years of experience in Quality Assurance, Regulatory Affairs, Laboratory Operations or a related field required.3+ years in progressive leadership experience required.
Experience managing quality/regulatory department of regional responsibilityExperience with data privacy regulations preferredExperience with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred.
RESPONSIBILITIES:
Leadership.
Strategic partnership with Global Quality Assurance team and Global Leadership TeamRegional oversight of Quality Assurance teamsDaily management activities for regional Quality Assurance TeamPromotion of high-performing culture through talent planning, selection, onboarding, and continuing educationDevelopment and delivery of comprehensive training plans and materials for successful onboarding and employee performanceOngoing coaching and mentorship with routine performance metricsIdentification of clear performance feedback and career development plansQuality Assurance.
Identification and implementation of strategies for maintaining a culture of qualityDevelopment and execution of a holistic audit program, covering internal audits, vendor audits, client audits, and regulatory inspections to ensure complianceUtilization of industry knowledge to enhance strategies and processes for delivering high-quality clinical trialsMaintenance of a working knowledge of industry and regulatory standards and requirementsProvision of guidance and leadership on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standardsResponsive escalation point for Clinical Trials quality issues and concernsProcess Improvement.
Development and execution of processes to enhance effectiveness, efficiency, and compliance in clinical trials and lab operationsCreation, refinement, review, and mitigation of quality Key Process Indicators (KPIs) to identify trends and drive improvementsCompliance.
Oversight and management of vendor management program for ensuring supply complianceOversight and management of computer systems validation program to ensure complianceOversight and management of regional data privacy program to ensure complianceRepresentation of company at client meetings, regulatory audits, and other relevant events
