QA Auditor III

• Conduct and/or lead client, internal, and GCP audits and regulatory inspections as requested by senior management
• 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 activities including database audits, clinical study report audits, sample results table audits, and process improvement
• Serve as a knowledgeable QA resource to operational departments
• Prepare and present audit findings and related information at departmental, internal operations, and client meetings
• Travel across EMEA up to 12–15 times per year, averaging 1–2 times per month

• Candidates must be located in Spain, the UK, or France and hold the legal right to work
• GCP auditing experience
• Investigator site audit experience
• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous QA experience comparable to 3+ years
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency leading project-based or internal GxP audits and vendor audits to required standards
• Excellent oral and written communication skills
• Strong problem-solving, risk assessment, and impact analysis abilities
• Solid experience in root cause analysis
• Above-average 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 work in an office/laboratory and/or clinical environment
• Ability to work around biological fluids, potentially infectious organisms, and electrical office equipment
• Ability to use required personal protective equipment
• Ability to work upright and/or stationary for 6–8 hours per day
• Ability to perform repetitive hand movements and frequent mobility
• Ability to occasionally crouch and stoop, and frequently bend and twist the upper body and neck
• Ability to lift and carry 15–20 lbs
• Ability to access and use in-house and off-the-shelf computer software
• Ability to communicate and understand spoken and written information
• Regular and consistent attendance

• Competitive sign-on bonus considered for qualified candidates
• Fully remote work arrangement
• Collaboration and development opportunities
• Exposure to a global team environment
• Corporate credit card for business travel, subject to qualification