Associate Director, R&D Quality Risk Management (GCP/GLP)

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Job Description

  • Co-leads the GCP and GLP 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 and GLP audits
  • 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 Clinical Development 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 and GLP 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.
  • Participates in Inspection Readiness and inspection execution
  • Coordinates and/or facilitates quality risk management activities at the process level across R&D.
  • Manages one or more QRM team members supporting the audit program or other QRM activities.


Qualifications

  • 8+ years pharmaceutical or biotechnology drug development experience
  • 5-6 years, GCP/GLP/GCLP/GRP, and/or QA or Compliance experience
  • 5-6 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 solid understanding of the GxP drug development regulations including USA (FDA), EU (EMA and MHRA), Japan (PMDA), ICH Guidelines 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.

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