Role OverviewPlan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
What You Will Do
Plan, schedule, conduct, report, and close audit activities to assess compliance with regulations/guidelines, customer requirements, IQVIA SOPs, and project-specific guidelines/instructions. Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
Why It Might Be a Fit
The ideal candidate will have 5 years of experience in pharmaceutical, technical, or related areas, with 3 years in Quality Assurance Audits. GCP experience is required, and experience in conduct of clinical trial Investigator site audits is preferred.
Requirements
- Bachelor's Degree (preferred)
- 5 years of experience in pharmaceutical, technical, or related areas
- 3 years of experience in Quality Assurance Audits
- GCP experience
- Experience in conduct of clinical trial Investigator site audits (preferred)
- Knowledge of word-processing, spreadsheet, and database applications
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments
- Knowledge of quality assurance processes and procedures
- Strong interpersonal skills
- Excellent problem-solving, risk analysis, and negotiation skills
- Strong training capabilities
- Effective organization, communication, and team orientation skills
- Ability to initiate assigned tasks and work independently
- Ability to manage multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Benefits
- Potential base pay range: $75,400.00 - $188,600.00
- Incentive plans, bonuses, and/or other forms of compensation
- Range of health and welfare benefits
]]>