For our Quality Assurance group in Europe we are currently recruiting a Manager of Quality Oversight to develop and implement client specific quality oversight programs.
You will be creating and delivering a comprehensive, global quality oversight plan in compliance with company SOPs (Standard Operating Procedures), GCP and clinical trials regulations.
The Manager of Quality Oversight:
- Provides expertise and guidance on global GCP topics, identifies compliance and quality trends and areas of potential compliance risk, proposes resolutions, oversees implementation of resolutions, and ensures effectiveness of solutions.
- Collaborates with internal functional areas to help maintain PRA’s high quality standards of clinical trial development.
- Develop, implement and maintain quality oversight plans, tools and templates
- May functionally manage 1- 5 colleagues within a matrix reporting structure
- Leads the implementation of client specific quality oversight plans for assigned clients, projects and/or portfolios.
- Ensures the quality oversight plan is completed according to internal requirements and agreed upon client expectations
- Liaises with project team leads (e.g. PM, CTM, etc.) on identified quality issues, quality/compliance trends, and works within the team to address and mitigate identified risks.
- Advises project team on global GCP regulations and guidance documents governing clinical trial development and serves as expert consultant to project teams and client representatives
- Oversees the development and finalization of all audit finding responses. Includes an assessment of completeness, compliance with GCP and PRA standards, and adequacy of response.
- Facilitates personally and/or ensures facilitation of all project, client and/or portfolio related quality issues (e.g.CAPAs) and ensures effectiveness checks are instituted in a timely manner
- Develops and delivers training on lessons learned through Audits and Inspections
- Leads the evaluation and management of site specific escalations related to persistent or serious misconduct.
- Participates, as requested, on quality related projects initiated by internal stakeholders
- Provides reports on quality trends, observations and suggestions to Management
- Liaises with the QA department in relation to inspection support requests and client audits, as appropriate
- Performs risk assessments and root cause analyses as needed
The role is home-or office-based in Netherlands and applicants must have excellent Dutch language skills.