Newly created role reporting to VP, Technology. If you have significant CSV / CSA / GAMP 5 experience within CRO, Pharma, Biotech apply today!
Associate Director / Director IT Quality & Compliance, Australia based
We’re Avance Clinical a Contract Research Organisation. We offer 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.
https://www.avancecro.com/news/frost-sullivans-2026-global-company-of-the-year/
We appreciate that our people are key to the success of our business hence we have fostered an exceptional, employee centric, culture with supportive teams and excellent career progression reflected in 23% of our people being promoted in the last 12 months.
Join us in this newly created role where you’ll lead the technology assurance function. You’ll have accountability for the quality, validation, governance and share the responsibility of information security of regulated and corporate systems with system and data owners. The role exists to give Sponsors, regulators, the executive team and Avance staff confidence that the systems used to deliver clinical trials are validated, controlled and resilient, and that clinical and corporate data is managed to a set standard.
You’ll lead the Computer System Validation (CSV) team within IT and work to shift the function from a prescriptive CSV model to a risk-based, CSA-ready approach integrated with agile delivery while preserving independent QA oversight. You’ll implement and operate the Avance Information Security Management System (ISMS), leveraging an ITSM platform as the authoritative system inventory along with ValGensis for validation lifecycle management, and governs a risk framework across IT systems, processes and people.
Representing us in client and regulatory audits of GCP validated systems, leading vendor qualifications where Avance is being assessed by a Sponsor, contributing to RFI and RFP responses on GCP systems and information management, assessing third-party vendors of clinical and corporate systems as part of a wider Vendor Management framework. You’ll protect Avance's reputation as a CRO that Sponsors trust with their clinical data.
Key responsibilities include