About This Role

As the Senior Manager, Global Safety Regulatory Sciences (GSRS) Quality PV/GCP, you will partner with functional area experts within the GSRS organization to work as their quality resource to manage quality issues, process improvement opportunities and other quality related tasks.  You will collaboratively perform audit and inspection readiness activities, for their assigned areas, and work with subject matter experts (SMEs) to evaluate systems for compliance, prepare SMEs for audit interviewing, and create storyboards

 What You’ll Do

·       Provide guidance and work with SMEs to evaluate processes for compliance to regulations and process improvements as needed. 

·       Work with areas to create and monitor key process metrics such as Key Performance Indicators (KPIs) or Key Quality Indicators (KQIs).

·       Review and approve controlled documents, process deviations and procedural edits, and manage on-time periodic review of documents 

·       Manage the GSRS global audit and inspection readiness program from preparation through completion of CAPAs for designated process areas, including preparing SMEs to present their functions during audits/inspections, aid in creating storyboards, and performing duties as the Audit coordinator.

·       Monitor commitments from internal audit and regulatory inspection findings and ensure accurate and timely completion of commitments.

 Who You Are

We are looking for someone who is passionate about Quality, loves to learn, and enjoys collaborating with many different functions.

Required Skills

·       Bachelor’s Degree; science, engineering or other technical areapreferred.

·       5-7 years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences and experience working in a quality or quality systems department

·       Direct experience in GCP and/or GVP regulations

·       Demonstrated leadership, problem solving, and conflict resolution skills

·       Ability to establish effective business relationships with external stakeholders, including implementing process change

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.