Clinical Auditing Specialist II/III – Vendor and Information System Audits Team

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Conduct and/or oversee external supplier GxP information systems audits, including on-site, virtual, questionnaire, and desktop audits of technological solutions implemented in clinical trials.

• Evaluate computerized-system processes such as QMS, SDLC, information security, data integrity, business continuity, disaster recovery, backup and restore, as well as data center/cloud hosting environments.

• Offer GxP regulatory advice and assistance to internal project teams and stakeholders regarding information-systems compliance requirements.

• Travel throughout EMEA at least four times annually.

• Prepare, document, and distribute audit reports and findings to departmental and cross-functional stakeholders.

• Contribute to the team’s Practical Process Improvement (PPI) initiatives.

• For level III, independently manage complex audits, assess quality or regulatory compliance issues, identify root causes, develop risk-based strategies, mentor junior auditors, and represent QA in senior cross-functional and client discussions.

⛳️ Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualifications.

• A minimum of 2 years of prior QA experience or similar experience.

• For level III, generally requires 5+ years of relevant QA experience.

• Proven leadership in GxP and vendor audits.

• Comprehensive knowledge of GxP and applicable regional research regulations and guidelines.

• Demonstrated expertise in executing various GxP audits to management standards.

• Working knowledge or familiarity with GAMP 5 R2, computer system validation concepts, 21 CFR Part 11 compliance, and SDLC.

• Exceptional oral and written communication skills.

• Strong problem-solving, risk assessment, and impact analysis capabilities.

• Solid experience in root-cause analysis.

• Above-average negotiation and conflict management skills.

• Ability to multitask, prioritize competing demands/workload, and work flexibly.

• Valid driver's license.

• Ability to qualify for and maintain a corporate credit card with a sufficient credit line for business travel.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.

• Corporate credit card with a sufficient credit line for business travel.

• Opportunities for collaboration and professional development.

• Reasonable accommodations for individuals with disabilities.

• Equal opportunity employment.