Manager, External Product Quality Assurance
About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity:
We have an exciting opportunity for External Product Quality Assurance Manager
to join our CMC Product QA EMEA Team in the UK, Ireland or Netherlands to work within our Quality Assurance division.
This is an exciting time to join Astellas as we expand our team in EMEA. As an organisation that aims to stand on the forefront of healthcare change, we are looking for self-motivated individuals to join us, could this be you?
Hybrid Working:
At Astellas we recognize the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- This position is responsible for all aspects of cGMP and related systems and processes supporting CMO Management.
- This position will serve as the main point of contact between Astellas and low risk external CMO’s for quality issues and has oversight of Supplier Evaluation Programs, Quality Agreements, Change Management, CMO Annual Product Reviews and Quality Risk Management.
- Responsible for managing the following quality systems for Astellas CMO products: Deviation Management (including CAPA), Change Control, Stability, Annual Product Review, Complaints, Supplier Evaluation, Quality Business Review Meetings and Regulatory Intelligence.
- Responsible for supporting Significant quality issue management, Risk Evaluation Committee and Audits.
Essential Knowledge & Experience:
- Proven compliance expertise; to understand and comply with industry laws and relevant regulations.
- Has QA/QC experience working in a GMP facility, OR supplier management experience with oversight of GxP facility.
- Good understanding of common manufacturing and QC processes and commonly used equipment, as well as validation requirements.
- Can manage small regional QA projects with limited number of participants. Can contribute to larger or cross functional projects representing QA.
- Demonstrable examples of ability to develop, coach and enable high performance teams and proactively promote best practice and knowledge sharing.
- With a good communication skill, support internal stakeholders and CMO with inspection preparation, inspection requests and with support inspection follow up.
Preferred Experience:
- Previous experience in pharmaceutical Quality Assurance, supplier oversight or in-plant GMP pharmaceutical manufacturing.
Educations/Qualifications:
- Bachelor’s degree or equivalent experience
Additional Information:
- This is a permanent, full-time position based in the UK, Ireland and Netherlands.
- We offer a hybrid working pattern, requiring travel once per quarter or in accordance with business requirements to the applicable office (Addlestone, UK, Leiden Netherlands or Killorglin, Ireland), blended with a collaborative video environment that supports working from home.
- The role involves some travel, mostly within Europe.
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.
