Description
Manager, Inspection Management
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
As a Manager in Inspection Management at Astellas Pharma, you will play a pivotal role in ensuring excellence in our Inspection Administration. You will be responsible for developing and implementing strategies that enhance our global inspection readiness and compliance across various quality assurance functions. Your contributions will directly impact our mission to improve patient care through innovative therapies.
Hybrid Working
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities
- Promote company-wide understanding of Quality Management Systems (QMS) and regulatory compliance.
- Evaluate inspection findings to identify process improvements.
- Conduct and coordinate routine and ad-hoc mock inspections.
- Stay updated on legal, regulatory, and industry standards, integrating them into education and inspection readiness.
- Drive regulatory compliance and sustainable process improvements.
Essential Knowledge & Experience
- Experience from within the Pharma, Biotech, Medical Devices or associated industry, including Quality Assurance.
- Strong communication, writing, and interpersonal skills, with the ability to interface across multiple departments and external stakeholders.
- Detailed knowledge of GXP regulations and quality principles, applying current interpretations to Quality documentation and record control.
Required Qualifications
- Experience from within Pharma, Biotech or related industry including QA experience.
- Must demonstrate effective communication, writing and interpersonal skills and the ability to interface across multiple departments and external stakeholders.
- Detailed knowledge of GXP regulations, other quality principles and applies current interpretations/trends to Quality documentation and record control.
Preferred Experience
- Experience in taking a lead with cross-functional teams and projects.
- Familiarity with inspection readiness benchmarking and industry forums.
- Proven track record in managing multiple projects efficiently.
Education/Qualifications
- BA/BS degree or equivalent experience.
Additional Information
- This is a full-time, permanent position.
- This position is based in the United Kingdom.
- This position follows our hybrid working model. Role requires a blend of home and minimum 1 day per quarter in our Addlestone office. Flexibility may be required in line with business need. 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.
