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:
We have a 6-month secondment position available for an External QA Manager, where you will be managing cGMP Quality Assurance for drug substances, intermediates, and finished products — including biologics and combination products — manufactured for Astellas by third-party CMOs. You’ll support other CMO Managers on-site or act as the main quality contact for low-risk external CMOs, communicating potential risks and collaborating with colleagues across the EU and globally in the US and Japan.
You’ll be driving key quality systems, covering deviation management (including CAPA), change control, SQIM, risk evaluations, audits, stability, annual product reviews, complaints, supplier evaluations, batch acceptance, SAP/UPS releases, Quality Business Review meetings, and regulatory intelligence — ensuring consistent compliance and quality excellence throughout the CMO network.
Hybrid Working:
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Responsibilities and Accountabilities:
CMO QA Oversight
- Overseeing cGMP activities for drug substances, intermediates, and finished products at low-risk CMOs, supporting the Head Manufacturing QA EMEA.
- Assisting CMO QA managers and participating in Business Review Meetings.
Quality System Assessment
- Facilitating resolution of deviations, non-conformances, and batch-related issues.
- Applying risk management to ensure all CMO products meet regulatory and Astellas standards.
- Participating in CMO evaluations, developing reports, and cooperating with Supply Chain, Purchasing, and Quality Systems to maintain approved CMO lists.
- Identifying and communicating major cGMP compliance issues and contributing to corrective/preventive actions.
- Supporting audits, inspections, and special plant reviews as required.
Compliance
- Embedding a culture of compliance and integrity across regions.
- Leading by example, challenging non-compliance, and ensuring adherence to ethics, regulatory standards, and HCP/HCO/PO interactions.
- Monitoring Significant Quality Issues (SQIs) and investigations, supporting QA assessments, record-keeping, and regulatory notifications.
QA Activities
- Supporting continuous improvement initiatives and building effective stakeholder relationships.
- Participating in Product Support Teams and maintaining departmental controlled documents.
- Monitoring CMO Quality Systems and contributing to Management and product quality reviews.
- Performing other duties as required by the business.
Essential Knowledge & Experience:
- Pharma 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 Knowledge & Experience:
- Previous experience in pharmaceutical Quality Assurance, supplier oversight or in-plant GMP pharmaceutical manufacturing.
Education:
- Science Graduate or equivalent professional qualification and/or proven expertise.
Additional Information:
- The is a 6-month secondment based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day a quarter in our Addlestone 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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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