At a Glance
- Tasks: Oversee quality leadership and compliance for service providers managing clinical studies.
- Company: Proclinical champions quality and compliance across clinical service providers worldwide.
- Benefits: This hybrid position offers flexibility to work from either London or Paris.
- Other info: Willingness to travel up to 20% as required.
- Why this job: Lead QA Operations in the GCP domain, ensuring high standards across operations.
- Qualifications: Master's degree in a relevant scientific field; experience in clinical studies required.
The predicted salary is between 60000 - 80000 £ per year.
Champion quality and compliance across clinical service providers worldwide. Proclinical 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.
Senior Manager, Lead QA Operations Service Provider (GCP) employer: Proclinical Group
Proclinical is dedicated to maintaining high standards in clinical studies globally. Employees enjoy a hybrid work model with locations in London and Paris. The team focuses on quality assurance expertise and compliance in the GCP domain.
