A leading, global pharmaceutical company is looking to hire a senior quality assurance auditor focusing on GCP - current good clinical practices.
Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures;
Plan, organize and lead multiple audits of external contract facilities (e.g. specialty testing laboratories, central laboratories, clinical sites, central Institutional Review Boards (IRBs), Contract Research Organizations, EDC, IVR and distributors as applicable) both within the US and globally to evaluate facilities, equipment, personnel, methods, practices, computer systems, records, storage, SOPs, policies and applicable government regulations; Maintain approved supplier list;
Work independently as well as a team;
Mentor, coach and train QA auditing staff;
Prepare and present project progress reports to update management and keep the team(s) informed
May assist or lead audits of investigative clinical sites to assess compliance with regulations, guidelines, policies, procedures and sponsor requirements;
Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate;
Experienced with current and pending FDA regulations, 21 CFR and ICH guidelines. Render training presentations on regulations, compliance and quality related subjects as requested. Maintain liaison with all appropriate vendor, inter-divisional and intra company departments and teams to ensure expeditious compilation of projects and corrective action for audit observations.
• 5-7 years Experience in Quality Assurance / Regulatory Affairs (Pharmaceutical preferred)
• 5-7 years Clinical Research Development
• 2-4 years QA Auditing Experience (GCP Auditing preferred)
Minimum of 7 years total combined experience required. (Not necessarily the sum of the above)