Associate Director / Director IT Quality & Compliance
Newly created role reporting to VP, Technology. If you have significant CSV / CSA / GAMP 5 experience within CRO, Pharma, Biotech apply today!
We're Avance Clinical, a Contract Research Organisation offering specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry, you'll know that we are experts in our field and have an unrivalled reputation for providing high‐quality service. We've grown every year since 2019, have doubled in size over the last 2.5 years and recently won the highest accolade within our sector.
Key Responsibilities
* Lead, develop and manage the Computer System Validation (CSV) team within IT, defining individual goals, learning paths and competencies aligned to the IT performance framework.
* Operate a risk‐based, CSA‐ready validation programme aligned to GAMP 5 (2nd Edition) and FDA CSA guidance, applying critical thinking and risk‐tiered scope so validation effort is proportionate to patient safety, data integrity and business impact.
* Implement, maintain and continually improve an Information Security Management System (ISMS) aligned to ISO/IEC 27001:2022 controls and integrated with the eQMS (MasterControl) for SOP advertisement, training compliance and document control, and with ISO 9001 quality management practices.
* Use the ITSM Configuration Management Database (CMDB) as the authoritative system inventory to drive governance decisions – criticality, GCP validation status, business and technical ownership, change approval workflow, dependencies and impact rating – across all regulated and corporate systems.
* Represent the organisation in client and regulatory audits of GCP validated systems, lead vendor qualifications where Avance is being assessed by a Sponsor, contribute to RFI and RFP responses on GCP systems and information management, and assess third‐party vendors of clinical and corporate systems as part of a wider Vendor Management framework.
Qualifications
* Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences or a related discipline; postgraduate qualification in quality, information security, regulatory affairs or business desirable.
* Minimum 10 years' experience in the pharmaceutical, biotechnology, medical device or CRO industry, with at least 5 years leading a Computer System Validation, IT Quality, IT Compliance or IT GRC function in a GxP‐regulated environment.
* Demonstrable expertise in GAMP 5 (2nd Edition), FDA Computer Software Assurance (CSA) guidance, 21 CFR Part 11, EU Annex 11 and ICH GCP E6 (R2/R3), with a proven record of moving an organisation from a prescriptive CSV model to a risk‐based CSA approach.
* Hands‐on experience managing the ValGenesis platform (or equivalent validation lifecycle management system) as system owner and as the enterprise tool for CSV governance.
* Exposure to ISO/IEC 27001:2022, ISO 9001 and ISO 27701. Hands‐on implementation, certification readiness and ongoing operation of an ISMS in a regulated organisation is highly desired.
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