GCP Audit Manager
Job Title: GCP Audit Manager
Location: Cambridge, MA
Duration: 7 month contract
Description: Responsible for managing the planning, conduct and reporting of GCP audits to assure adherence to corporate and R&D policies and procedures, Biogen internal standards, and compliance with regulatory requirements and guidelines. The R&D 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). The GCP Audit Manager will be responsible for managing the planning, conduct and reporting of R&D audits to assure adherence to corporate and R&D policies and procedures, Biogen internal standards, and compliance with regulatory requirements and guidelines.
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. No travel required. * Primary responsibility is managing GCP Audits (Clinical Investigator Site, Vendor, TMF and Internal Process audits) Plan audits with vendor auditor * Facilitate pre-audit activities to ensure audit scope is adequate * Author Individual Audit Plans * Facilitate post-audit debriefs * Review and approve Audit Reports * Ensure deliverables are timely and adequate and meet quality expectations * Assist with escalating audit observations that are critical or of significant safety impact * Assist with other audit types which may include GCLP/GLP/GVP Internal Process and External Vendor audits
Additional Job Requirements:
Note: this role is not responsible to perform audits. No travel required. Good Clinical Practice (GCP) Excellent communication skills, both verbal and written Excellent project management skills Able to work independently in a cross-functional, multi-cultural team 4 + years pharmaceutical or biotechnology drug development experience 4+ years GCP and/or QA or Compliance experience and/or 4+ years of audit or audit management experience
Sthree US is acting as an Employment Business in relation to this vacancy.