Description
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.
- Lead and/or participate in GCP site and vendor audits in accordance with standard operating procedures, quality policies and/or plans.
- Appropriately and expeditiously escalate GCP compliance issues.
- Communicate audit results to management and auditees through written audit reports.
- Ensure key stakeholders are informed of non-compliances identified during audits.
- Manage post-audit follow-up on any necessary corrective and preventive actions; resolves any conflicts to closure
Requirements:
- 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
- Proven ability in driving quality process improvement initiatives.
- Extensive leadership experience and mentoring skills Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines
- Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
- Experience in providing training on key quality and regulatory compliance information
- Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, etc.
- Accomplished knowledge of global and local GCP regulations
To find out more about Real please visit www.realstaffing.com