Associate Director of Quality Assurance and

1 month ago

York North Yorkshire, United Kingdom Pivot Search Full time

Associate Director Quality Assurance
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)

Bachelor’s Degree (required)
~ Master’s Degree (preferred)
~7+ years of experience in Quality Assurance, Regulatory Affairs, Laboratory Operations or a related field required.
~Experience managing quality/regulatory department of regional responsibility
~ Experience with data privacy regulations preferred
~ Experience with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); Strategic partnership with Global Quality Assurance team and Global Leadership Team
Regional oversight of Quality Assurance teams
Daily management activities for regional Quality Assurance Team
Promotion of high-performing culture through talent planning, selection, onboarding, and continuing education
Development and delivery of comprehensive training plans and materials for successful onboarding and employee performance
Ongoing coaching and mentorship with routine performance metrics
Identification of clear performance feedback and career development plans
Quality Assurance.
Identification and implementation of strategies for maintaining a culture of quality
Development and execution of a holistic audit program, covering internal audits, vendor audits, client audits, and regulatory inspections to ensure compliance
Utilization of industry knowledge to enhance strategies and processes for delivering high-quality clinical trials
Maintenance of a working knowledge of industry and regulatory standards and requirements
Provision of guidance and leadership on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standards
Responsive escalation point for Clinical Trials quality issues and concerns
Creation, refinement, review, and mitigation of quality Key Process Indicators (KPIs) to identify trends and drive improvements
Oversight and management of vendor management program for ensuring supply compliance
Oversight and management of computer systems validation program to ensure compliance
Oversight and management of regional data privacy program to ensure compliance
Representation of company at client meetings, regulatory audits, and other relevant events

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