Senior Compliance Specialist(GCP) - Remote U.S

Location: Remote, North Carolina, United States of America

Category: Quality & Regulatory

Employment Type: Full time

Work Schedule

Environmental Conditions

Job Description

As a Senior Compliance Specialist within the Inspections team, you will be responsible for managing all aspects of GxP regulatory authority inspections at CRG, investigator sites, and clients. The majority of the work is focused on the Americas region; however, inspection support in other regions is also in scope.

What Youll Do:

• Provide consultation to project teams and clients on GxP inspection readiness, preparation, management, and follow-up activities. 
• Serve as the primary point of contact for inspection-related discussions with clients. 
• Support GxP regulatory authority inspections of CRG, investigator sites, and sponsors (preparation, facilitation and hosting, QC of documents, post-inspection follow-up, review of responses to inspection findings).
• Support mock inspections.
• Conduct inspection preparation activities, including but not limited to, risk assessment (identification of issues quality and regulatory compliance) and development of mitigation strategies; training of involved inspection personnel; conducting mock interviews; staging of documents; preparing of presentations and storyboards, etc.
• Support project teams in investigating root causes of non-conformances and in developing CAPAs to address identified issues; follow up on action implementation, effectiveness checks, and the collection and review of supporting evidence. 
• Contribute to lessons learned discussions and participate in company-wide improvement initiatives. 
• Perform document reviews and other GxP activities in support of project work or company processes.
• Serve as a resource and provide GxP consultation to operational departments and external clients on inspection or quality assurance subject matter.
• Provide mentorship and guidance to junior colleagues.

Education & Experience Requirements:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous 5+ years of quality assurance experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

• Extensive knowledge of GxP (GCP required) along with a strong understanding of applicable regional research regulations and guidelines.
• Experience with management of GxP inspections (GCP inspection experience mandatory)
• Excellent oral and written communication skills
• Strong problem solving, critical thinking, risk assessment and impact analysis abilities
• Above average negotiation and conflict management skills
• Confirmed experience in root cause analysis
• Flexible and able to multi-task and prioritize complex demands/workload
• Veeva QMS and auditing experience a plus
• Valid drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Working Conditions and Environment:

• Work is performed in an office environment.
• Exposure to electrical office equipment.

*Must be legally authorized to work in the United States without sponsorship. 

*Must be able to pass a comprehensive background check, which includes a drug screening.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.