R&D GLP Audit Manager

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Job Description

• Manage the planning, conduct, approval, and close-out of audits performed by contract auditors (note: this role is not responsible to perform audits)
• Lead the GLP/GCLP/GRP annual audit strategy including risk-based approach for selection of audits for vendors and Biogen Internal processes
• Manage end-to-end audit processes to ensure the coordination and execution of audit scope and follow-up activities with relevant Pre-Clinical and Clinical Development Stakeholders
• Facilitating pre-audit activities to ensure audit scope is adequate and authoring of Individual Audit Plans
• 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 audit, CAPA and Quality Issue Management, observational trend analysis, etc.
• Contribute to identification of relevant audit trends and drive process improvement initiatives to implement process changes to address any gaps
• Contribute to/lead assessment of GLP/GCLP/GRP 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

Qualifications

• 5+ years pharmaceutical or biotechnology drug development experience
• 4+ years, GLP/GCLP/GRP, and/or QA or Compliance experience
• 4+ years in any of the following areas: audit or audit management experience, inspection readiness, CAPA management, or related quality management system responsibilities
• 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, Biotechnology, Regulatory Science, Regulatory Compliance, or Drug Development preferred
• Working knowledge and awareness of any of the following: FDA (21 CFR part 58), OECD Principles of Good Laboratory Practices, MHLW, ICH, Bioanalytical Guidance documents, GCLP and general compliance and audit concepts



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

965792880