DescriptionSenior Manager, Data Integrity Quality AssuranceAbout Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing 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: In this role, you will be responsible for directing the Data Integrity governance activities applicable to GMP/GDP globally. You will serve as the Data Integrity Officer for GMP/GDP areas, providing management and strategic leadership to develop and manage the Data Governance Program. Additionally, you will contribute to the development, implementation, and successful execution of the QA mission, objectives, and long-term strategic plan. Hybrid Working: At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. Key Activities for this role:
Executing the DIQA compliance oversight program, ensuring issue resolution, audits, and regulatory inspection preparation. Providing regulatory intelligence and interpret requirements to support global process improvement initiatives. Developing and implementing quality strategies for Data Integrity compliance and technology solutions, leading initiatives across multiple departments. Supporting the DIQA internal and vendor audit program, ensuring compliance assessments, audits, and corrective actions. Collaborating with business functions to lead continuous process improvements in data integrity and regulatory compliance.
Essential Knowledge & Experience: Substantial pharmaceutical industry experience paired with Quality Assurance expertise. Effective communication, writing, and interpersonal skills for interfacing across departments and with external stakeholders. Detailed knowledge of GXP regulations, computerized systems in GXP environments, and quality principles. Expertise in global industry standards and regulatory requirements for software development, computer system validation, data integrity, and Electronic Records/Signatures. Ability to interact with regulatory agencies globally and develop effective relationships with internal and external stakeholders. Preferred Qualifications: Problem-solving skills to define business needs, identify possible solutions, and develop executable plans with available resources. Capability to work effectively in culturally diverse situations. Application of processes, methods, skills, knowledge, and experience to achieve specific project objectives within agreed parameters, timescales, and budgets. Ability to document processes in straightforward, easy-to-understand explanations and instructions within a QA subject. Education/Qualifications: A bachelor's degree or equivalent experience is required. Fluency in English is essential for effective communication with global stakeholders. Additional Information: This is a permanent, full-time position. This position is based in London, UK This position follows our hybrid working model. The role requires a blend of home and approx. 1 day per quarter in our London 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. #LI-Addlestone#LI-Hybrid
