About This Role

As the Senior Manager, Global Safety Regulatory Sciences (GSRS) Quality, 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 

·       Approve CAPAs and review for effectiveness. Responsible for maintaining evidence record in support of inspection readiness

·       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.

·       Provide support during GVP and GCP regulatory inspections.

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

·       Evaluates GSRS systems for optimization and continuous improvement

 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 area preferred.

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

·       Comprehensive knowledge of GxP and other regulations and understanding of global quality standards relating to product development, submission and/or commercialization.

·       Direct experience in GCP or GVP regulations

·       Demonstrated ability to translate external and internal quality and compliance trends into QA practice and to disseminate relevant data to the larger organization to further enhance overall quality and compliance levels.

·       Demonstrated leadership, problem solving, and conflict resolution skills

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

·       Ability to initiate, build and maintain strong cross-functional and cross-divisional business relationships and positively influence key, strategic position holders across locations and functions.

·       Demonstrated ability to effectively work within a global environment.

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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.