About the Role

As the Senior Manager, R&D Quality and Compliance, you will partner with quality and compliance functions and work with subject matter experts (SMEs) to maximize the value of each audit, drive complex multi-functional CAPAs, execute the regulatory intelligence, quality risk management and change control processes.  Additionally, you will provide support for inspections and participate in other quality risk management activities across R&D.  

Note: this role is not responsible to conduct audits.

What You’ll Do

·       Supports the GCP annual audit strategy including risk-based approach for selection of audits for vendors, Biogen internal processes and clinical sites to maximize the value of each audit

·       Oversees the planning, conduct, approval, and close-out of audits performed by contract auditors for GCP audits. Oversees other GxP audits as required.

·       Oversees the execution of the end-to-end audit processes to ensure the coordination and execution of audit scope and follow-up activities with relevant stakeholders

·       Provides subject matter expertise (SME) in the development and review of procedural documents related to audit, CAPA and Quality Issue Management, observational trend analysis, etc.

·       Contributes to identification of relevant GxP trends and drives process improvement initiatives to implement process changes to address any gaps or inefficiencies

·       Contributes to/leads assessments of GCP related quality issues

·       Participates in CAPA management process including direct or indirect implementation of actions resulting from observations/quality issues, reviewing and approving CAPA responses, etc.

·       Coordinates and/or facilitates quality risk management activities at the process level across R&D

·       Coordinates and/or facilitates the GCP Regulation monitoring, assessment, and implementation process

·       Manages sponsor inspection readiness preparations, inspection conduct, response generation and adherence to inspection CAPA commitments

Who You Are

You have a passion for quality and enjoy working with stakeholders and quality colleagues to manage quality risks. You love continuous learning and solving problems through collaboration.

#LTD-1

·       Experience in any of the following areas: audits, inspection management, inspection readiness, CAPA management, quality risk management or related quality management system responsibilities

·       Working knowledge and understanding of the GCP drug development regulations including USA(FDA), EU (EMA and MHRA), Japan (PMDA), China (CFDA), ICH Guidelines and general compliance and audit concepts

·       5+ years GCP and/or QA or Compliance experience.

·       Bachelor’s Degree  

Preferred Qualifications:

·       Life Sciences, Biotechnology, Regulatory Science, Regulatory Compliance, or Drug Development preferred

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.