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Director Quality Assurance - Biometrics - Clinical Services - Walloon Brabant

Company

Our Client is a Statistical and eClinical services provider (CRO) in the field of clinical research

Role

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

Profile

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)

Offer

  • A unique opportunity to work in an innovative, dynamic and future-oriented company.
  • A strong international environment.

Publication date

01.01.2021

Contact person

Sophie Gravy

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