Associate Director Quality Assurance

3 weeks ago

York, United Kingdom Pivot Search Full time

Associate Director Quality Assurance


SUMMARY:

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 responsibility
  • Experience with data privacy regulations preferred
  • Experience 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 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

Process Improvement.

  • Development and execution of processes to enhance effectiveness, efficiency, and compliance in clinical trials and lab operations
  • Creation, refinement, review, and mitigation of quality Key Process Indicators (KPIs) to identify trends and drive improvements

Compliance.

  • 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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