GCP Audit Manager
Proclinical is currently recruiting for a Good Clinical Practice Audit Manager for a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for managing the planning, conduct and reporting of GCP audits to assure adherence to corporate and R&D policies and procedures, company's internal standards, and compliance with regulatory requirements and guidelines.
- Manage the planning, conduct, approval, and close-out of audits performed by contract auditors.
- 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.
Skills and Requirements:
- 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.
- Excellent communication skills, both verbal and written.
- Excellent project management skills.
- Able to work independently in a cross-functional, multi-cultural team.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Zachary Hines at (+1) 215-531-6914 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.