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

Job not on LinkedIn

🔥 0 minutes ago

🌐 United Kingdom, Serbia, +3 more countries – Remote

🇬🇧 United Kingdom – Remote 🇷🇸 Serbia – Remote 🇧🇪 Belgium – Remote 🇧🇬 Bulgaria – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Conduct and/or lead external supplier GxP information systems audits, including on-site, virtual, questionnaire, and desktop audits of technology solutions used in clinical trials • Assess computerized-system processes including QMS, SDLC, information security, data integrity, business continuity, disaster recovery, backup and restore, and data center/cloud hosting environments • Provide GxP regulatory consultation and support to internal project teams and stakeholders on information-systems compliance requirements • Travel across EMEA at least four times per year • Prepare, document, and issue audit reports and observations to departmental and cross-functional stakeholders • Contribute to the team’s Practical Process Improvement (PPI) efforts • For level III, independently lead complex audits, evaluate quality or regulatory compliance issues, determine 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 qualification • 2+ years of previous QA experience or comparable experience • For level III, typically 5+ years of relevant QA experience • Demonstrated leadership of GxP and vendor audits • Thorough knowledge of GxP and applicable regional research regulations and guidelines • Demonstrated proficiency in conducting a range of GxP audits to management standards • Working knowledge or familiarity with GAMP 5 R2, computer system validation concepts, 21 CFR Part 11 compliance, and SDLC • Excellent oral and written communication skills • Strong problem-solving, risk-assessment, and impact-analysis abilities • Solid root-cause-analysis experience • 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 sufficient credit line for business travel

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule • Corporate credit card with sufficient credit line for business travel • Collaboration and professional development opportunities • Reasonable accommodation for individuals with disabilities • Equal opportunity employment