About This Role:

As the Associate Director, R&D Quality Culture you are responsible for leading key quality initiatives aimed at maturing the R&D Quality Management System (QMS). You will partner with stakeholders across Biogen to develop and implement methods and tools to drive a culture of quality throughout the organization. 

This position is open to candidates residing in Switzerland. 

What You’ll Do:

·       Lead large, global, complex projects related to Quality Culture, QMS development/expansion and Quality systems

·       Develop and implement methods to drive a culture of Quality across R&D; lead and/or contribute to the development of Quality and Compliance messaging for all levels of the organization. Drive an understanding of the R&D QMS inside and outside of R&D (e.g., Biogen Global Affiliates, Worldwide Medical).

·       Lead discussions to harmonize the R&D risk tolerance

·       Periodically measure, analyze, and report on the maturity of the QMS and gain cross-functional alignment on priorities of QMS initiatives for continuous improvement

·       Provide support to the Quality sub-process owners to identify training needs and develop training content.  Processes include but are not limited to Audit, Inspection, Quality Risk Management, Quality Issue Management and Regulatory Intelligence.

·       Develop and deliver Quality and Compliance training for R&D including topics related to the R&D QMS, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and Good Research Practice (GRP)

Who You Are:

You are passionate about Quality and love to learn new things. You enjoy solving complex problems and bringing people together towards a common goal.

Required Skills:

·       Ability to influence without authority and lead others through change.

·       Strategic and tactical project leadership skills. High attention to detail including proven ability to manage multiple, competing priorities and to prioritize appropriately.

·       Experience leading global, complex, cross-functional teams.

·       Experience leading or executing some or all Quality activities including but not limited to Audit, Inspection, Vendor Management, Controlled Documentation, Deviations, Training, Quality Risk Management and Regulatory Intelligence.

·        Bachelor’s Degree required, Masters/PhD optional – Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred

·        8 - 10 years pharmaceutical or biotechnology drug development experience including 5-8 years GxP QA or Compliance experience

Preferred Skills:

·        In-depth understanding of GCP, GCLP, GVP, GLP, and/or GRP regulations and industry best practices

#LI-TD1

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.