Thermo Fisher Scientific · 11 hours ago
Sr Compliance Specialist, GxP Non-Compliance-- fully remote!
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expThermo Fisher Scientific is the world leader in serving science, committed to helping customers find cures for cancer and supporting medical inquiries. The Sr Compliance Specialist will develop and execute quality and compliance strategies, oversee governance processes, and provide guidance to maintain regulatory standards across the organization.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Develops and executes quality and compliance strategies and initiatives across the organization, including promoting awareness of quality and regulatory compliance standards and trends
Oversees governance and compliance management processes including quality events, serious breach events and suspected scientific misconduct events
Develops and maintains quality and compliance guidance/reference materials and tools and provides expertise to advance the vision of the department
Leads quality and compliance processes and engages with cross-departmental staff to ensure appropriate execution and completion (e.g., quality events, serious breach events, suspected scientific misconduct events, supports inspections and audits)
Develops guidance and reference information, repositories and communication channels (e.g., requests for information/ proposals (RFI/RFP), policies, procedures, guidance documents or quality management systems training)
Creates formal networks with key contacts across the department
Qualification
Required
Bachelor's degree is required
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
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years') or equivalent combination of education, training, & experience
Experience Working With GCP Is Required
Demonstrated ability to use critical thinking is required
Expertise in applicable GxP and appropriate regional regulations
Extensive knowledge of the clinical trial process
Expert knowledge of SOPs and WPDs
Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
Strong training/mentoring experience of staff on a variety of process/topics
Strong attention to detail
Effectively works independently or in a team environment
Highly developed problem solving, risk assessment, and impact analysis skills
Strong negotiation and conflict management skills
Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load
Strong computer skills; ability to learn and become proficient with appropriate software
Proven flexibility and adaptability
Must be able to pass a comprehensive background check, which includes a drug screening
Preferred
At least 2 years in Clinical Quality, GCP Compliance or related is preferred
Experience in CAPA, root cause analysis, and deviation management is preferred
Demonstrated ability to communicate complex compliance issues clearly and effectively is preferred
Comfortable working in a matrix organization and managing cross-functional customers is preferred
Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is preferred
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Marc Casper
CEO
Stephen Williamson
Senior Vice President and Chief Financial Officer
Recent News
Genetic Engineering News
2026-01-16
Investor's Business Daily
2026-01-16
Company data provided by crunchbase