Description
Provide proactive GCP Quality and compliance oversight and guidance to assigned functional areas and stakeholder groups within the Clinical Development organization.Essential duties & responsibilities but not limited to the following:
- Assist with development of the audit strategy and programs.
- Assure timely execution of approved audit programs and schedule.
- Provides oversight and directs training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing..
- Identify/monitor GCP compliance risks;provide guidance on mitigation/management of such risks.
- Lead and/or support GCP inspection readiness and inspection management activities.
- Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams.
- Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry
- Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP
- Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
- Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards
- Extensive experience supporting regulatory authority inspections of clinical research activities
- Hands-on experience managing quality and compliance projects and programs
To find out more about Real please visit www.realstaffing.com