General Information

Job Advert Title
Senior Manager, Quality Services (Audit)
Location
United Kingdom
Function/Business Area
Quality
Department
Quality Assurance
Employment Class
Permanent

Description

Quality Systems, Senior Auditor


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 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.


About This Job


As the QS Senior Auditor you will be responsible for conducting and leading on internal and external audits to include identifying and evaluating risks in support of the Supplier Evaluation Program for all Astellas clinical and commercial products across EMEA.


Essential Knowledge & Experience


  • Previous experience of leading high volumes of external audits, including suppliers (contract manufacturers CMO’s) and development partners.
  • Comprehensive knowledge of global GMP & GDP requirements including robust and demonstrable understanding EU Directives, EU GMP & GDP regulations, ICH Guidelines, QMS requirements. The role holder will perform audits as per the audit plan to conduct approximately  15 – 20 audits  per annum as lead auditor, and perform as co-auditor or observer as directed, on approximately 15- 20  other audits.  
  • Proven leadership to achieve quality goals, while developing measures to monitor the effectiveness of the IT-QA function itself and drive remediation for improvement.
  • Demonstrable experience of implementing Continuous Improvement within the QS Audit function.
  • Develops and maintains effective relationships with internal and external stakeholders, which may include regional and global Astellas entities.
  • Global matrix experience working collaboratively with a broad range of internal & external stakeholder.

Preferred Knowledge & Experience


  • Pharmaceutical Audit experience, or
  • Project Management qualification – Lean Six Sigma
  • Educations/Qualifications
  • Graduate or equivalent professional qualification in sciences area
  • Certified auditors – IRCA

Additional information


  • Office based but with flexibility to work from home due to large amount of travel required in the role, approx. 60% travel across Europe to affiliates and external suppliers.


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.