QA Clinical Auditor II

• Conduct and/or lead client, internal, GCP audits and regulatory inspections
• Perform directed site, facility, vendor and subcontractor audits
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and participate as a co-auditor in complex system audits
• Perform QA audits and activities including database audits, clinical study report audits, sample results tables and process improvement
• Serve as a QA and audit subject-matter resource to operational departments
• Prepare and present audit findings and related information at departmental, internal operations and client meetings
• Work in office/laboratory and/or clinical environments
• Follow required personal protective equipment and physical/attendance requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous QA experience
• Knowledge of GCP and appropriate regional research regulations and guidelines
• Proficiency leading project-based or internal GCP audits and vendor audits
• Excellent oral and written communication skills
• Strong problem solving, risk assessment and impact analysis abilities
• Experience in root cause analysis
• Negotiation and conflict management skills
• Ability to multitask and prioritize competing demands/workload
• Valid driver's license
• Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
• Ability to access and use in-house and off-the-shelf computer software
• Regular and consistent attendance

• Global team environment
• Collaboration and development opportunities
• Scientific excellence-focused workplace