About 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 the management and oversight of Astellas’ Quality Assurance (QA) vendor oversight program, ensuring vendors involved in GxP regulated activities meet the highest standards of compliance. You will play a critical role in maintaining adherence to regulations such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and Electronic Records/Signatures (ERES) and Computerized System Validation (CSV).
You will define and implement the QA vendor audit strategy, as well as execute the broader QA Vendor Management strategy, ensuring consistent, quality vendor oversight. This includes assessing vendors through risk ranking methodologies and conducting quality evaluations to guarantee their compliance. The role also involves developing, executing, and maintaining a robust Vendor Management strategy to meet annual objectives and drive continuous improvement in vendor performance and regulatory 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:
- Contributing to the strategic direction of QA Vendor Management and collaborating with global stakeholders.
- Developing, implementing, and executing the QA vendor audit strategy in partnership with QA functions.
- Leading the creation of vendor audit schedules based on tier assignments, risk ratings, and compliance.
- Overseeing vendor audits, maintaining the vendor list, and ensuring clear communication of vendor status to Astellas and regulators.
- Managing vendor risk mitigation, evaluating quality metrics, and escalating issues to drive resolutions with vendors and stakeholders.
Essential Knowledge & Experience:
- Substantial experience in the pharmaceutical, biotechnology, or related industry, with a strong understanding of regulatory requirements and quality standards.
- Proven expertise in GxP (GCP, GVP, GLP, ERES, CSV, and/or GMP) and Quality Management Systems, with a focus on quality oversight of vendors providing GxP regulated services.
- Demonstrated ability to drive results and effectively implement deliverables within tight timelines and complex environments.
- Skilled in managing multiple initiatives and projects simultaneously, ensuring timely completion and high-quality outcomes.
- In-depth knowledge of GxP requirements for both investigational and marketed products, ensuring compliance at every stage of development and lifecycle.
Preferred Qualifications:
- Significant experience in auditing and vendor relations.
- Strong hands-on experience and understanding of Vendor Management as applied throughout the entire pharmaceutical compound/product life cycle.
- Proficiency in Microsoft Office.
Education/Qualifications:
- A bachelor's of science degree or equivalent.
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.
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