Senior Compliance Specialist – GCP

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Manage all aspects of GxP regulatory authority inspections at CRG, investigator sites, and clients • Provide consultation to project teams and clients on GxP inspection readiness, preparation, management, and follow-up • Serve as primary point of contact for client inspection-related discussions • Support inspections of CRG, investigator sites, and sponsors, including preparation, facilitation, hosting, document quality control, post-inspection follow-up, and review of responses to findings • Support mock inspections • Conduct risk assessments and develop mitigation strategies • Train inspection personnel, conduct mock interviews, stage documents, and prepare presentations and storyboards • Support root-cause investigations and development of CAPAs • Follow up on action implementation, effectiveness checks, and supporting evidence • Contribute to lessons-learned discussions and company-wide improvement initiatives • Perform document reviews and other GxP activities supporting project work or company processes • Provide GxP consultation to operational departments and external clients on inspection and quality assurance matters • Mentor and guide junior colleagues

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous 5+ years of quality assurance experience, or equivalent combination of education, training, and experience • Extensive knowledge of GxP, with GCP required • Strong understanding of applicable regional research regulations and guidelines • Experience managing GxP inspections, with 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 • Ability to multitask and prioritize complex demands/workload • Veeva QMS and auditing experience a plus • Valid driver's license • Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities to participate in the job application or interview process and perform essential job functions • Benefits and privileges of employment