Thermo Fisher Scientific · 8 hours ago
GCP Process Lead, FSP Clinical Compliance
United States
Full-time
Remote
Senior Level
6+ years expThermo Fisher Scientific is a company focused on advancing science and healthcare. As the GCP Compliance and Process Lead, you will play a pivotal role in driving quality and compliance strategies, ensuring adherence to regulatory standards and implementing advanced quality assurance processes.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Facilitate and manage cross-functional teams' GCP inspection readiness activities throughout the study lifecycle
Embed real-time inspection readiness strategies into daily operations, collaborating with study teams
Provide just-in-time guidance on key operating model processes and required documentation, prioritizing real-time inspection readiness
Manage and guide teams on inspection readiness planning, developing and maintaining readiness plans and tools
Facilitate the development of key inspection deliverables, including functional presentations and study team preparation for audits
Ensure high-quality deliverables for global studies by guiding adherence to operational processes and documentation
Champion proactive prioritization of inspection readiness, focusing on GCP process excellence
Engage with subject matter experts in inspection readiness activities and study-level risk assessments
Coordinate and manage TMF performance and processes, ensuring compliance and inspection readiness
Lead and participate in meetings for assigned projects, ensuring effective communication and addressing customer concerns
Maintain project management documentation, including plans, timelines, and progress reports
Coordinate activities to enable study team readiness for internal audits and regulatory inspections
Manage functional teams during inspections, collaborate with SMEs, and ensure timely follow-up
Qualification
Required
Good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring
Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field; with at least two years specifically supporting clinical Quality & Compliance
Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes
Proven awareness of sponsor oversight requirements and regulations
Experience in problem solving, negotiations, and collaborative team building and other collaborators is required
Strong understanding of regulatory requirements within clinical trials, industry standards, and related documentation needs
Must be able to efficiently apply computer software programs like Microsoft Office for general use, project management, and presentations
Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Domestic/international travel (5-20%) may be required
Preferred
Preferred experience with inspection preparation, including hands on regulatory inspection activities
Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
Bachelor's degree preferred or commensurate with experience
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
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
Company data provided by crunchbase