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Director of External Service Provider Quality Assurance
hace 2 meses
Job Title: Associate Director, External Service Provider Quality
Location: London Westworks, United Kingdom (with options for Dublin, Ireland / Barcelona, Spain / Madrid, Spain)
Working Model: Hybrid (12 days per month in the office)
About the Role:
As our Associate Director External Service Provider QA, you will play a pivotal role in managing external service providers across GxP areas in Global R&D; Quality, ensuring that our partners meet the highest standards of excellence.
Key Responsibilities:
- Provide QA expertise and guidance to ensure compliance with quality system requirements, including implementation of quality risk-based and GxP-relevant processes.
- Review and approval of External Service Providers (ESP) qualifications, ensuring adequate Quality Assurance Agreements (QAA) / quality terms are in place.
- Lead and manage quality oversight, collaborating with business partners and other quality groups to ensure health authority and regulatory requirements are fully met.
- Translate functional QA strategy into applicable operational/compliance activities, supporting a risk-based implementation and execution of processes.
- Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP.
- Ensure communication and support mitigation of actions for potential risks, addressing quality and compliance gaps for sustainability and implementing strategic process improvement.
- Monitor implementation of the Quality Plan, supporting inspection readiness activities, including participation in regulatory inspection preparation, management, and follow-up.
- Support Audit team for audit planning and timely completion of audit CAPA, as well as clinical trial team for oversight/management of external service providers and IT systems supporting research and development activities.
Requirements:
Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis, and corrective actions implementation.
What We Offer:
A dynamic and challenging role in a leading organization, with opportunities for growth and development.
