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Manager, Quality Assurance, Technology & Data
About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.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.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.The Opportunity:
As a Manager, QA Technology & Data, you will be responsible for leading and executing audit and validation programs for Astellas' Information Systems. This includes ensuring compliance with company standards, policies, and global regulations for electronic records and computerized systems.
You will manage audits of vendors, service providers, and internal processes, support new technology initiatives, and drive process improvements. Additionally, you will help maintain compliance with Good Practice (c Gx P) standards and contribute to Astellas' long-term QA strategy.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 Responsibilities:
- 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.
- Assist 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.
- 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, to resolve compliance issues, report to management, and to ensure completion of quality related action items.
- Ensure and facilitate compliance with global Electronic Records / Electronic signatures regulations (e.g., 21 CFR Part 11) and provide quality and compliance guidance in areas of continuous improvement, innovation, and validation.
Essential Knowledge & Experience:
- In-depth knowledge of Gx P regulations and computerized systems in Gx P 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.
- Excellent oral and written communication as well as presentation skills.
Preferred Qualifications:
- Advanced degree in related disciplines.
- Previous experience in managing staff (contractors/consultants, full-time employees, or both).
Educations/Qualifications:
- Bachelor of Arts/ Bachelor of Science degree, or equivalent.
Additional information:
- This is a permanent, full-time position.
- Fluent in written and spoken business English.
- 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 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 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.