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 caregivers, 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:
As the Development Product Quality Assurance (DPQA) Manager, you will facilitate and implement the DPQA strategy to ensure the development and validation of high-quality and compliant products in both regional and global settings. This role provides QA oversight and services for the manufacturing, testing, packaging, labeling, and distribution of Clinical Trial Material (CTM) / Investigational Medicinal Product (IMP). You will lead QA activities, and risk management processes, and resolve critical issues across multiple projects. You will also act as the QA representative on project teams to provide direction on quality and compliance, escalate issues, and ensure the timely completion of related action items. In addition, you will support Qualified Persons (QPs) in release activities and perform assigned tasks as a trainee QP.
Key Activities for this role:
- Manage GMP QA activities for multiple projects requiring CTM support in manufacturing, packaging, labeling, and distribution for both regional and global Astellas products in the development phase.
- Review and approve technical documents and process-related deliverables/changes for cell therapy, biologics, and small molecule developmental compounds.
- Lead supplier issue resolution by leveraging product-specific knowledge and understanding.
- Lead the development and execution of quality strategies for CTM QA and support cross-functional coordination to ensure on-time delivery of CTM.
- Support product transitions to Commercial Readiness QA and collaborates with regions for product launches.
- Lead CMO (supplier) audits and new supply chain initiatives; support CMOs during regulatory authority inspections.
Essential Knowledge & Experience:
- A Dutch pharmacist degree or equivalent, including a BA/BS in a science field, that qualifies for QP eligibility in the Netherlands after training.
- Experience working in a manufacturing or operational QA role at a licensed manufacturing site.
- In-depth knowledge of GMPs relating to product development and related regulations.
- Strong communication, interpersonal, facilitation, and influencing skills with the ability to work effectively across teams and external stakeholders.
- Experience with GMP auditing, vendor audits, and regulatory inspections.
- Demonstrated ability to develop and execute quality strategies with management guidance.
- Strong decision-making skills in quality-related areas with oversight from management.
Preferred Experience:
- Knowledge of global industry standards and regulatory requirements (US, EU, Japan).
- Experience in CTM QA.
- Knowledge of biologics, parenteral, regenerative medicines, or new modalities.
- Fluent in written and spoken business English.
Education/Qualifications:
- Dutch pharmacist degree, BA/BS in a science field or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in the Netherlands.
- Willingness to travel, mostly within the EU.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per month in our Dutch 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.
