Senior Auditor, Quality Assurance - Tech QA team

Sr Auditor, QA - remote - Bulgaria or Poland

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Senior Auditor (Technology & CSV)

The role:

We are currently seeking a Senior Auditor Quality Assurance to join our diverse, dynamic and passionate Tech QA team. In this role, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

What you will be doing:

• Utilizing a strong knowledge of regulatory expectations and industry knowledge you will provide expert consultancy and compliance advice within ICON for current and emerging technology related topics, such as eClinical Systems and AI.
• Perform a variety of audit activities including internal process audits (with a technology component), technology vendor audits, computerized system and equipment audits.
• Perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems.
• Participate as a Technology related Subject Matter Expert during inspections, sponsor audits and in support of Quality Issues.
• Mentor and train junior staff.

Your profile:

• Bachelor's degree in Life Sciences, Pharmacy, IT or related field; advanced degree preferred. 
• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare or CRO industry.
• Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues spanning multiple systems and/or business areas.
• Proven auditing experience of computerized systems, processes and vendors used in a clinical development and manufacturing setting.
• In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks and emerging trends (e.g. 21 CFR Part 11, Annex 11 & EMA Guidance, Computer Software Assurance, Agile, ITIL, GDPR, Information Security, AI).
• Familiar with regulations and guidance governing clinical trials and drug development (e.g. ICH, FDA, EMA covering GLP, GCP, GVP, GMP, GDP and Medical Devices).
• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
• Ability to travel more than 20%. 

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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