Our Client is a Statistical and eClinical services provider (CRO) in the field of clinical research
Director Quality Assurance – Biometrics – Clinical Services
In this position, your responsibilities will be to:
- Manage and support QA team members in Belgian Headquarters and in the US (as from end of 2021)
- Liaise with managers and teams to ensure that the Quality System is optimal
- Ensure the maintenance and conformity of eQMS documents and systems
- Ensure the delivery of all QA related trainings
- Follow up on the review of personnel records
- Contribute to the development and maintenance of SOPs and policies
- Supervise the organization, conduct and follow up of client, internal, partner and supplier/vendor audits
- Participate in the development and review of CSV documentation for all validated systems and provide advice in the process of study specific validation.
- Ensure and contribute to good management of non-conformities and CAPA
- Ensure the appropriate and regular update of legal documentation (GCP regulations, EU regulations, national regulations) and on-time information and training to employees.
- Manage the governance with critical providers
At least 10-year pharmaceutical industry experience in the capacity of a QA auditor or equivalent
- Solid experience with GCP in a pharmaceutical company/CRO/vendor or with quality assurance systems such as ISO standards are required
- Knowledge and understanding of the clinical research environment and randomization, data management and statistics work processes
- Experience in Computer System Validation.
- Good interpersonal skills (communication, organizational and time management skills)
- Proven ability to manage a team
- Ability to solve problems and to motivate others
- Fluent written and oral English
- Training skills including presentation experience is preferred
- Good working knowledge of Microsoft Word and Excel
- Detail and quality oriented
- Is able to work both independently and within a team.
- Open to travel (to the US: 2 to 3 times a year)
