CQV Project Manager
Blackfield Associates are looking for a CQV Project Manager to be based on a 12-month contract in Chartres, France.
Responsibilities
This project is part of a global investment initiative at the Chartres site, focused on expanding the site’s production capacity for cartridge filling and inspection. The project also includes the development of a Clean and Industrial Utilities facility, as well as an effluent neutralization plant.
The Commissioning, Qualification, and Validation (CQV) Project Manager is responsible for overseeing and managing the execution of all commissioning, qualification, and validation activities associated with the building and utilities. This role involves coordinating multiple teams and stakeholders to ensure adherence to regulatory requirements and quality assurance throughout the project’s lifecycle.
Additional responsibilities include:
Manage, Monitor, and Coordinate Project Activities:
- Set clear goals for the CQV team.
- Contribute to project risk mapping and mitigation strategies.
- Participate in the project board meetings and track Key Performance Indicators (KPIs)
Develop and Maintain the CQV Execution Schedule:
- Collaborate with project teams to define objectives and deadlines for deliverables (e.g., protocols, reports).
- Ensure timely delivery of project milestones.
- Oversee project progress in terms of goals, quality, timeline, and budget.
- Allocate appropriate resources to ensure project success.
Resource and Skill Management:
- Identify necessary internal and external resources and skills based on project technical requirements.
- Supervise and develop team members as needed by providing constructive feedback to improve team members’ technical capabilities.
- Set and monitor annual goals for the team.
- Support skill development according to project needs.
Establish and Implement Governance with Stakeholders:
- Maintain and update project-related documentation, ensuring the highest quality standards are met.
- Guarantee the reliability of results through adherence to GMP, company standards, ISO standards, and proper validation processes.
Requirements
- Pharmaceutical Industry Experience: 15+ years
- CQV Project Management Experience: 5+ years
- French fluency: Must be able to interpret documentation in French