Champion quality and compliance across clinical service providers worldwide.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is seeking a Senior Manager to lead QA Operations for Service Providers within the GCP domain. This role is pivotal in ensuring quality oversight and compliance of service providers involved in clinical studies and programs. You will collaborate closely with Clinical Development Operations, Global Medical Affairs, and Procurement teams to provide quality assurance expertise and maintain high standards across operations.
This hybrid position offers flexibility to work from either London or Paris.
Responsibilities:
- Oversee quality leadership and compliance for service providers managing clinical studies.
- Develop and maintain quality systems to ensure adherence to regulatory and ethical standards.
- Implement and manage Quality Agreements with service providers using a risk-based approach. Conduct service provider qualification, including audits and quality assessments.
- Lead Service Provider Quality Oversight Meetings and ensure action traceability.
- Monitor and report on service provider performance, promoting best practices and improvement initiatives.
- Support inspection readiness activities and act as a subject matter expert during GCP inspections.
- Collaborate with internal teams to align quality agreements with legal contracts.
- Contribute to training sessions and ensure appropriate training materials are available.
- Manage quality representatives and oversee team objectives, development, and performance.
- Ensure compliance with EHS regulations and promote a culture of safety within the team.
Key Skills and Requirements:
- Strong knowledge of Good Clinical Practices (GCP) and experience in interventional/non-interventional clinical studies.
- Proven ability to manage quality systems and oversee service provider compliance.
- Analytical skills to address complex problems and define effective CAPAs.
- Master's degree or higher in a relevant scientific field; additional qualifications in Quality or a PhD are advantageous.
- Fluent in English; additional language skills are a plus.
- Excellent communication and collaboration skills to work with cross-functional teams.
- Willingness to travel up to 20% as required.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.
Apply Now:
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杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
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