Senior Director Quality Assurance, Data Integrity, Technology & Data

General Information

Job Advert Title Senior Director Quality Assurance, Data Integrity, Technology & Data Location United Kingdom Function/Business Area Quality Employment Class Permanent

Description

Senior Director Quality Assurance, Data Integrity, 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:
In this role, you will be responsible for ensuring global compliance for all computer system validation, data integrity processes, information systems, and electronic records supporting research & development, clinical development, manufacturing and commercial manufacturing operations at Astellas.
You will develop and maintain strategic partnerships with senior leadership and management across the organization to drive excellence in data integrity and compliance.
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 Responsibilities:

• Ensuring compliance with global data integrity regulations and industry standards.
• Overseeing computer systems and data management processes for clinical studies, regulatory submissions, and manufacturing.
• Providing QA oversight of validation and compliance of all computer systems supporting R&D, clinical development, manufacturing and commercial operations.
• Partnering with management to monitor quality performance, identify risks, and lead improvement initiatives.
• Contributing to the QA mission and strategic plan, providing global quality oversight.

Essential Knowledge & Experience:

• Extensive experience in the pharmaceutical industry, particularly in Quality Assurance.
• Proven leadership in managing projects and staff in a global, matrixed environment.
• Expertise in global industry standards and regulatory requirements for Data Integrity and computer system validation.
• Skilled in managing internal and vendor audits and supporting regulatory inspections.
• Strong communication, facilitation, and influencing skills across global teams and stakeholders

Preferred Qualifications:

• Strong written and verbal communication skills to effectively convey information and achieve desired outcomes with the intended audience.
• Excellent problem-solving skills to define business needs, identify solutions, and develop executable plans with available resources.
• Ability to build and maintain networks of relationships within the industry or business area, leveraging connections to accomplish tasks and sustain long-term relationships.

Education:

• A university degree in IT, Science, Biotechnology, or a related field, or equivalent.
• 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-London #LI-Hybrid