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.
About This Job:
As a Manager, Quality Assurance, Technology & Data, you will be responsible for managing and executing the Technology and Data Quality Assurance (TDQA) audit and validation oversight programs related to regional Astellas Information Systems processes for computer systems, technology solutions, clinical and commercial systems, data integrity processes, and related process improvement initiatives within Quality Assurance (QA).
You will be in charge of operational management to drive consistent current Good Practice (cGxP) compliance and validation approaches to ensure compliance with Astellas standards, policies, and procedures. You must ensure compliance with global Electronic Records / Electronic signatures regulations and related cGxP regulatory requirements.
You will be responsible for managing the TDQA audit program related to audits of vendors, service providers, and internal processes in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for computer systems. Develops, facilitates, and implements process improvements and supports new technology initiatives as Astellas continually invests in new technology solutions and computerized systems. Contributes to the development, implementation, and successful execution of the QA mission, objectives, and 3–5 years strategic plan.
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:
- Manage, coordinate, plan, and administrate the TDQA program to oversee the computerized systems validation program and ensure reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures. Report status of validation projects to management.
- Assists TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs. Interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project-related initiatives. Manage programs and resources necessary to support assigned projects.
- Identify, develop, facilitate, and manage process improvement initiatives that relate to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas. Manages multiple projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives.
- Serve as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, resolve compliance issues, and management report, and ensure completion of quality-related action items.
- Ensure and facilitate compliance with global Electronic Records / Electronic signatures regulations (e.g., 21 CFR Part 11). Provide quality and compliance guidance in areas of continuous improvement, innovation, and validation. Collaborate, advise and provide consultation on quality matters to individuals, study/core teams, and functional management teams across the Astellas organization.
Essential Knowledge & Experience:
- In-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends.
- In-depth knowledge of global industry standards and regulatory requirements for software development, computer system validation, and Electronic Records and Electronic Signatures regulations. Experience in these disciplines in the pharmaceutical industry.
- Regulated (FDA, EMA, MHLW, ISO, or other) computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required. Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
- Experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams. Collaborative skills to facilitate, manage, and work within project teams across departments and global organizations.
- Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.
- Excellent oral and written communication as well as presentation skills.
- Fluent in written and spoken business English.
Preferred Qualifications:
- Proven experience in managing staff (contractors/consultants, full-time employees, or both).
Education/Qualifications:
- Bachelor of Arts/ Bachelor of Science degree or equivalent.
Additional Information :
- This is a permanent, full-time position.
- This position is based in the United Kingdom and the Netherlands.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our United Kingdom and/or Netherlands office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.
