Job Overview
JOB DETAILS
The Opportunity:
As the Risk and Compliance, Infrastructure Controls & Compliance, you are responsible for leading, supervising, and coordinating IT infrastructure quality, control, and compliance efforts for DigitalX TechX Risk & Compliance. In this role, you will lead the definition, implementation, promotion, and oversight of the quality and compliance controls framework and strategy. Ensure comprehensive coverage across all DigitalX global infrastructure platforms, including physical, cloud, internally managed, and vendor-supported environments.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Activities for this role:
Transform the Astellas model for infrastructure compliance, away from legacy ‘qualification and documents’ approach towards an agile enabled ‘tools and records’ approach which will run in lockstep with technical delivery.
Set an optimal compliance posture which balances risk (regulatory compliance, control, quality) against overhead, speed, agility, costs etc.
Prepare an infrastructure control & compliance strategy/roadmap, support the R&C Lead to align and incorporate the roadmap into the overall (R&C) Risk & Compliance strategy, and manage its execution.
Advise and support DigitalX stakeholders, peers, and leadership regarding risk, quality, and compliance considerations for Astellas global infrastructure platforms.
Interact and communicate with external and internal compliance community stakeholders.
Quality, compliance, and control oversight for infrastructure service providers, including initial assessment and ongoing governance, monitoring, and collaboration.
Essential Knowledge & Experience:
Extensive experience required, with demonstrated ability in managing infrastructure compliance disciplines within a pharma organisation.
Comprehensive understanding of (GxP) Good practice regulations ( (GLP) Good Laboratory Practice, (GCP) Good Clinical Practice , (GMP) Good Manufacturing Practice, (GDP) Good Distribution Practice , (GPvP) Good Pharmacovigilance Practice, etc), guidance, pharma industry norms, initiatives, and directions.
Strong judgment, creativity, leadership, and communication skills.
Education/Qualifications:
Bachelor’s degree in computer science or business, or equivalent.
Are you interested in this position?
Apply by clicking on the “Apply Now” button below!
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