Associate Director, R&D Quality and Compliance Auditing (GCP)
Professional Diversity Network
Cambridge, MA, USA
Information Technology (IT)
The Associate Director, R&D Audit has primary ownership for the GCP Audit program. S/he has audit management responsibilities, independently leading the planning, conduct and reporting of internal and external audits to assure adherence to Biogen's internal standards, and compliance with regulatory requirements and guidelines. S/he provides direction and oversight of vendor auditors to enable timely execution of audits and review and approval of audit reports and responses. Note: this role is not responsible to conduct audits.
* Strategic development and ownership of the GCP Audit Program for R&D (includes GCP Investigator Site Audits, GCP Vendor Audits, and GCP Internal Process/QMS Audits) * Manage 1 or more GCP Audit Team members * Lead the audit risk-assessment process and development of the Annual Audit Plan * Develop Individual Audit Plans, provide oversight of the vendor auditors and review and approve Audit Reports. Partner with functional stakeholders to maximize the value of each audit. * Periodically observe contract auditors during an audit to provide oversight and verify adequacy * Review and analyze audit metrics and trends and provide feedback to stakeholders for risk management * Lead and/or participate on process improvement initiative teams, as required * Less frequently, manage other R&D audits which may include GCP/GCLP/GLP/GVP Internal Process and External Vendor audits
* 8+ years pharmaceutical or biotechnology drug development experience * 5+ years Quality Assurance or Compliance experience * 5+ years of audit or audit management experience * Knowledge of international GxP drug development regulations, including USA
The Research & Development Audit Team is responsible for managing 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).