Director of Validation - CSV

Highly Competitive
  1. Permanent
  2. Validation
  3. United Kingdom
London, England
Posting date: 15 Feb 2024

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking an IT Compliance and Computer System Validation Specialist to be located anywhere in Europe. The successful candidate will play a pivotal role in supporting the business with the implementation, development, and management of compliance-related electronic systems. The role involves leading validation activities for the identification, installation, and application of compliance-related computer systems. The specialist will ensure that computerised systems are implemented, maintained, and operated in accordance with EU/Annex 11, GAMP, FDA/21 CFR part 11 and Data Integrity GxP requirements (specifically GCP, GLP and GMP) and any other applicable regulations.


  • Support supplier assessments for systems and internal audits of processes utilising computerised systems.
  • Provide training and support for the validation and development of computer related compliance systems.
  • Maintain excellent working relationships with the business and system suppliers.
  • Ensure System Reviews are conducted, providing suggestions to continually improve end user experience and supporting upgrades as required.
  • Liaise with the QA Supplier Assurance team to support internal and supplier software audits.
  • Assure training and support to ensure users are proficient in the validation of compliance related computer systems.
  • Assist in performing external audits for the qualification and management of IT and CSV suppliers.
  • Represent the company as SME for IT and computer systems validation during regulatory inspections and audits.
  • Lead the Data Governance program, identify and deploy continuous improvement initiatives and monitor effectiveness.

Key Skills and Requirements:

  • Demonstrable experience working in a GxP environment with focus on IT compliance and CSV.
  • IT literate, experience implementing, managing and operating IT systems, particularly eQMS.
  • Knowledge of GxP regulations and guidelines with regards to computer system validation and operation.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.