Manager, Data Integrity Quality Assurance
About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
As the Manager,
Data Integrity Quality Assurance (DIQA), you will play a pivotal role in ensuring data integrity across our global operations. Leading governance activities related to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), you will ensure compliance with regulatory standards. Your contributions will directly impact our mission to improve patient care through innovative therapies. Join us in our commitment to shaping the future by maintaining the highest quality in our data processes.
Hybrid Working:
At Astellas, we recognise that our employees enjoy having a 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.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities for this role:
- Execute the Data Integrity Quality Assurance (DIQA) compliance oversight program, ensuring strict adherence to data integrity regulations and guidelines.
- Conduct audits and support preparations for regulatory authority inspections, ensuring prompt issue resolution and compliance across Astellas.
- Develop and implement quality strategies for data integrity compliance, translating them into prioritized objectives for the DIQA and QA departments.
- Collaborate across departments to drive continuous improvements in data integrity and regulatory compliance processes.
- Provide expert guidance on data integrity practices, staying informed on evolving industry trends and regulatory expectations.
Essential Knowledge & Experience:
- Extensive industry experience with a strong background in Quality Assurance.
- Demonstrated ability to communicate effectively, both in writing and in interpersonal interactions, with the capacity to engage across multiple departments and stakeholders.
- In-depth knowledge of GXP (Good Practice) regulations and computerized systems in regulated environments, preferably within the pharmaceutical industry.
Preferred Experience:
- Experience with global industry standards and regulatory requirements for software development and data integrity.
- Familiarity with Electronic Records and Electronic Signatures regulations.
- Ability to interact with regulatory agencies across various geographies.
Education:
Additional Information:
- This role is full-time permanent.
- This role is based in London, United Kingdom.
- This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per quarter in our local 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.
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