General Information

Job Advert Title
Quality Assurance Lead & Responsible Person (m/w/d)
Function/Business Area
Quality Assurance
Employment Class


Quality Assurance Affiliate Lead & Responsible Person

Location: Austria

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

This is a new position in Austria for an experienced QA Lead to support the affiliate by leading and managing the affiliate Quality Assurance (QA) department, acting as the primary contact for any quality issues within the affiliate. And contributing to the development and successful implementation and execution of the QA Affiliate goals and objectives as per the QA Mid Term Plan.

Essential Knowledge & Experience

  • The successful candidate will have relevant experience in a comparable role in the pharmaceutical industry.
  • You will have had experience as an RP on license or deputizing (as long as listed on license - as defined in EU GDP Guideline 2013/C 343/01 ) and proven experience maintaining effective relationships with external bodies including national competent authorities.
  • Significant experienced in handling regulatory interfaces such as inspections and audits.
  • High sense of ethics and compliance culture. 
  • You will have demonstrable experience within multi-disciplinary, matrix and cross-cultural settings.
  • Track-record of leading planning process with excellent organisational and collaboration skills. 
  • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
  • Fluent in written and verbal business English

Preferred Knowledge & Experience

  • Experience working within Pharmacovigilance/or working closely with Pharmacovigilance Leads
  • Educations/Qualifications
  • Minimum of Degree in a science/health-related subject.
  • RP qualified
  • Member of professional bodies and/or associations

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.