Description
Essential duties and responsibilities include but are not limited to the following:- Development of the audit strategies and programs using risk based methodology to assure timely execution of company's approved audit schedule
- Provides hands-on training of CQC staff (internal and external) in all aspects of GCP/GVP compliance and compliance auditing
- Actively manage and/or support regulatory inspections and hosting partner audits
- Identifying/monitoring GCP/GVP compliance risks and providing guidance on mitigation/management of such risks to clinical development teams
- Ensure timely development of audit schedule, assist in the preparation and conduct of audits in collaboration with the Director, CQC
- Ensure that all the appropriate Standard Operating Procedures are current and implemented, to include training materials and conduct training
- Manage, assemble and coordinate the activities of the audit teams; internal and external auditors
- Lead and/or participate on GCP site and vendor audits in accordance with company's standard operating procedures, quality policies and/or plans.
- Organize and ensure that key stakeholders are informed of non-compliances trends identified during audits
- Manage post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts to closure in a timely manner
Requirements:
- Expert knowledge of technical concepts required for all aspects of GCP and GVP auditing, to include all types of GCP and GVP audits; e.g., Study Sites, Vendors, essential study documentation, Pharmacovigilance operations and databases
- Solid understanding of domestic and international pharmaceutical/Biotechnology process and auditing standards
- Strong leadership experience and mentoring skills to ensure CQA team members have the coaching and mentoring to increase accuracy and productivity
- Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines and GVP compliance initiatives and regulations globally
- Experience managing/supporting regulatory authority inspections
- Balanced approach to issue management and mitigation planning
- Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, Drug Safety Database functionality, etc.
Education:
- Bachelor of Science Degree or higher
- Experience: Accomplished knowledge of global and local GCP and GVP regulations
- Licenses or Certifications: RQAP-GCP or other certifications are highly desirable
- Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry
- Minimum of 7+ years' auditing in one of the following areas: GCP & GVP
To find out more about Real please visit www.realstaffing.com