Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Location: IRELAND ONLY - Office/Hybrid/Remote considered.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

We're seeking a highly motivated and experienced Clinical Auditing Specialist III to join our dynamic team. As a global leader in the industry, Thermo Fisher Scientific is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a company that values inclusion and collaboration, where diverse experiences, backgrounds, and perspectives are highly valued.

In this role, you will work with the Clinical Support Group working with a variety of teams to ensure the quality and compliance of our support systems as well as the opportunity to conduct and lead a variety of client and regulatory inspections.

Responsibilities:

• Perform risk based review of highly complex validated systems

• Lead directed site audits, facility, vendor, and/or sub-contractor audits

• Provide Gx P consultation and support to project teams and external clients

• Lead process audits and may participate as a co-auditor in more complex system audits

• Perform other types of QA audits or activities such as internal audits, non-conformance review and investigation review.

• Serve as a resource to operational departments on audit or quality assurance subject matter

• Prepare and present audit findings and related information at departmental, internal operations, or client meetings

• Attend site as required in order to perform client audits, regulatory inspections, internal audits and other activities as required

• Provide mentorship and guidance to junior auditors

Requirements:

• Bachelor's degree in a related field

• Minimum of 5 years of experience in clinical auditing or quality assurance

• Strong knowledge of Gx P regulations and guidelines

• Exceptional attention to detail and ability to ensure flawless execution of audits

• Proven ability to successfully implement audit processes and procedures

• Excellent communication and presentation skills

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.