Principal Validation Specialist

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.

What you will be doing:

The primary responsibility of the Principal Validation Specialist will be to support the R&D Quality Compliance & Systems function by providing QA&C support of computer system validation (CSV) activities in Research & Development. The Data Systems QA & Compliance Specialist will assure compliance with applicable GxP regulations and Companies standards (SDLC); advising the R&D IT Business Partner and R&D system owners/management on riskrelated matters pertaining to R&D systems.

Key responsibilities for this role are to provide professional expertise and guidance in applicable regulations (e.g., 21 CFR Part 11, Annex 11, and ICH E6(R2)) and industry standards (e.g., ISPE GAMP 5) as applicable to the Company’s R&D GxP environment (GCP, GLP, GVP, GDP). Additional duties include but not limited to liaising with various internal R&D functions, IT, and contract auditors and assisting stakeholders in maintaining systems within a state of compliance while providing recommendations for process improvement.

You are:

• Bachelor’s degree required with a life science focus preferred; Masters Degree in management or scientificdiscipline a plus.• Solid pharmaceutical experience and solid knowledge in validation and or audit program management.• Broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech area (ideally within the clinical and/or non-clinical areas), the management and conduct of audits, stakeholder focus, and strong knowledge of regulatory requirements.

• Extensive knowledge of regulatory requirements and standards for the use of computerized systems (21 CFR Part 11, EC Annex 11, and GAMP 5). Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations as applied by FDA, EMA and MHRA.•Good understanding of the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs a plus.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.