About This Role

The Senior Manager, Global Regulatory Sciences Quality will support to oversee all regulatory matters to ensure Global Safety & Regulatory Sciences (GSRS) complies with applicable regulations.  This position will partner with GSRS Regulatory staff assigned process owners within R&D to work as their quality resource to manage quality issues, process improvement opportunities and other quality related tasks.  This role will also support the GSRS audit and inspection readiness activities, for their assigned areas, and work with Regulatory subject matter experts (SME) to evaluate systems for compliance, prepare SME 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. 

·       Partner with GSRS Regulatory Process and Sub-Process owners to act as Quality Representative in assigned areas.  This includes:

o   Providing guidance and working with Regulatory subject matter experts to evaluate processes for compliance to regulations

o   Make process improvements as needed. 

o   Deliver Quality Issue and CAPA training as required

o   Prepare and participate in cross functional CAPA Review Board Meetings to maintain on time completion of CAPAs. 

o   Approve process deviations and procedural edits. 

o   Mentoring CAPA owners on proper techniques

·       Facilitate timely GVP/GCP audit responses and evaluate proposed corrective actions, and/or preventative actions, including effectiveness checks for compliance with applicable regulations, guidelines, and Biogen procedures.

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

·       Support GVP and GCP regulatory inspections

·       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 Regulatory & Quality, loves to learn, and enjoys collaborating with many different functions.

Required Skills

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

·       Minimum 6 years of applicable pharmaceutical drug development/clinical experience

·       Minimum 3 years of Regulatory Affairs-related Quality Assurance

·       Strong working knowledge of GVP and GCP regulations and guidelines.

·       Experience in regulatory authority inspections.

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

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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.

The base compensation range for this role is $116,700 to $187,900. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.