Senior Compliance Specialist(GCP) - Remote U.S

Thermo Fisher Scientific•Wilmington, NC

1d•Remote

About The Position

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. Join Us as a Senior Compliance Specialist - Make an Impact at the Forefront of Innovation 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.

Requirements

Bachelor's 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.
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
Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Nice To Haves

Veeva QMS and auditing experience a plus

Responsibilities

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.