The R&D Audit team’s primary responsibility is the overall management of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Laboratory Practice (GLP) Quality Assurance audits in support of the Biogen Research & Development Quality Management System (R&D QMS).
The Senior Manager, R&D Audit is responsible for managing the end to end processes related to the planning, conduct and reporting of GCP audits, with additional responsibilities in support of R&D Quality Risk Management including such activities as GCP quality advising and risk identification, inspection readiness, and CAPA management. 

Key responsibilities:

• Manage the planning, conduct, approval, and close-out of audits performed by contract auditors (note: this role is not responsible to perform audits)
• Primary responsibility for managing GCP Audits (e.g. for a specific clinical development drug program(s) or subtype of audit including Clinical Investigator Site, Vendor and Internal Process)
• Contribute to GCP annual audit strategy including risk-based approach for selection of audits 
• Manage end to end audit processes to ensure the coordination and execution of audits and follow-up activities with relevant stakeholders
• Facilitate pre-audit activities to ensure audit scope is adequate and author Individual Audit Plans
• Escalate audit observations that are critical or of significant safety or quality impact 
• Review and approve Audit Reports
• Oversee designated external contractors to ensure quality and timeliness of deliverables including periodically observing auditor performance 
• Provide subject matter expertise (SME) in the development and review of procedural documents related to the Quality Management System (e.g., audit, CAPA and Quality Issue Management, regulatory inspections, quality risk management)
• Contribute to the identification of relevant audit trends and drive process improvement initiatives to address gaps and improve efficiency
• Contribute to/lead assessment of GCP related quality issues
• Participate in CAPA management process including direct or indirect implementation of actions resulting from observations/quality issues, reviewing and approving CAPA responses, etc.
• Participate in Inspection Readiness and inspection execution activities

Essentials Skills and Qualifications Required:

• 5+ years pharmaceutical or biotechnology drug development experience
• 4+ years, GCP, and/or QA or Compliance experience
• 4+ years in any of the following areas: audit or audit management experience, inspection readiness, CAPA management, related quality management roles e.g. vendor management, training and records management
• Excellent communication skills, both verbal and written
• Excellent project management and leadership skills
• Able to work independently as well as in a cross-functional, multi-cultural team
• Education and Experience Requirements
•  Bachelor’s Degree required, Masters/PhD optional – Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred
• Knowledge of ICH GCP, FDA, EMA, other related ICH and general compliance and audit concepts
   

The Senior Manager, R&D Audit is responsible for managing the end to end processes related to the planning, conduct and reporting of GCP audits, with additional responsibilities in support of R&D Quality Risk Management including such activities as GCP quality advising and risk identification, inspection readiness, and CAPA management. It is located in Cambridge, MA and reports into the Associate Director R&D Audit.