GCP Process Lead, FSP Clinical Compliance

Work Schedule

Environmental Conditions

Job Summary

As the GCP Compliance and Process Lead at Thermo Fisher Scientific, you will play a pivotal role in driving world-class quality and compliance strategies. This is an exceptionally outstanding opportunity to influence and improve our healthcare operations, ensuring flawless execution of regulatory standards. Your expertise will be crucial in determining and successfully implementing advanced quality assurance processes.

Role: GCP Process Lead, FSP Dedicated

Location: Remote, USA

Key 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

Qualifications

• 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
• Preferred experience with inspection preparation, including hands on regulatory inspection activities
• 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 with CROs and outsourced clinical trial activities, sponsor experience preferred
• 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
• Bachelor’s degree preferred or commensurate with experience
• 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

Inclusion and Collaboration

At Thermo Fisher Scientific, we value diverse experiences, backgrounds, and perspectives. Our inclusive culture fosters collaboration and innovation, empowering each team member to contribute to our mission of advancing science and healthcare.