About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
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.
Additional Information:
- This is a permanent, full-time position.
- Position is based in Addlestone, UK.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per month in the Addlestone office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
What We Offer:
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.