Associate Director of Client Quality (Europe)
PrimeVigilance
- Lisboa
- Permanente
- Horário completo
- Oversight of Client Quality activities across all clients. Working closely with the Senior Quality Director and the Vice President of Quality to ensure all aspects of PrimeVigilance Quality Management System and the Clients Quality Management System are being adhered to by the Project.
- Ensure seamless delivery of all aspects of the Quality Cycle for Clients.
- Timely and complete training of the Client Quality Group.
- Create and maintain the structure and processes governing the activities of the Client Quality Group.
- Oversee all activities of the Client Quality Group, including but not limited to:
- Regulatory Intelligence
- Ensure a process is maintained and monitored for review the weekly and monthly regulatory intelligence.
- SOPs and Joint Operating Guideline
- Support Client Quality Managers with authoring client specific procedures and processes.
- Human Resources
- Perform routine review of forecasted resources against actual resource for the group.
- Ensure that all resources on the project are sufficiently qualified and that all project team members keep their CV, JD and training records up to date.
- Systems and Facilities
- Maintain oversight and ensure that any necessary Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP) are in place for projects and systems as needed and that such plans are tested regularly.
- Training
- Create and maintain a training matrix is maintain for the Client Quality Group.
- Provide training for the Client Quality Group as required.
- Maintain oversight of training for Client Quality group.
- Quality and Compliance Monitoring
- Review and monitor Client Quality Group metrics.
- Audits and Inspections
- Ensure that the Client Quality Group is audit and inspection ready at all times.
- Support Client audits and inspections as required.
- Contribute to any risk assessment activities performed by the Quality Assurance team for the Client Quality Group.
- Deviation and CAPA Management
- Support the Client Quality Group with deviation and CAPA management.
- Lead any deviations and CAPAs associated with the Client Quality Group activities.
- Life science graduate, pharmacy, nursing or other healthcare related qualification
- Line Management experience
- Strong PV QA experience
- Strong organisational skills
- Strong communication skills
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships