Manager, External Product Quality Assurance
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:
Your role ensures GMP compliance and quality oversight for contract manufacturers, maintaining adherence to Astellas standards and industry regulations. Serving as the primary liaison between Astellas and external manufacturers, it manages supplier evaluations, quality agreements, change control, annual product reviews, and risk management. Quality risks are identified and communicated for appropriate action in collaboration with regional and global teams. Key responsibilities include handling deviations, audits, stability programs, complaints, and regulatory intelligence to uphold high-quality standards.
Key Responsibilities:
- CMO QA Oversight – Manage GMP compliance and quality processes for Astellas products manufactured by CMOs, including deviations, non-conformances, and batch-related quality issues.
- Supplier and Risk Management – Assess and oversee supplier quality systems, participate in CMO evaluations, and ensure corrective/preventive actions using a risk-based approach.
- Regulatory Compliance – Provide QA support for regulatory inspections, ensure adherence to Astellas policies, and support coordination of recalls and regulatory notifications.
- Technology Transfers & Continuous Improvement – Oversee QA aspects of technology transfers between CMOs and contribute to process improvements within the quality management system.
- Stakeholder Collaboration – Work with Supply Chain, Purchasing, and Quality Systems teams to maintain an approved CMO list and align on compliance expectations.
- Surveillance of Quality Issues – Monitor and assess significant quality issues (SQIs), lead investigations, and ensure resolution in line with corporate policies and regulatory expectations.
Essential Knowledge & Experience:
- Science Graduate or equivalent professional qualification and/or proven expertise.
- Pharma, Chemistry or biology sector experience.
- Proven compliance expertise; to understand and comply with industry laws and relevant regulations.
- Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
- Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
- Fluent in written and verbal business English.
Preferred Experience:
- Previous experience in pharmaceutical Quality Assurance, CMO oversight or in-plant GMP pharmaceutical manufacturing.
Education:
Additional information:
- This is a permanent full-time position.
- Position is based in the Netherlands, UK or Ireland.
- This position follows our hybrid working model. Role requires a blend of home and minimum 1 day per quarter in our 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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