GCP Compliance and Process Lead, FSP

Position Overview

• Location Type: Onsite
• Job Type: Full time
• Salary: Not provided

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.

Requirements

• Experience: Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field.
• Knowledge: Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes.
• Awareness: Proven awareness of sponsor oversight requirements and regulations.
• Experience (Preferred): Experience with CROs and outsourced clinical trial activities.
• Skills: Experience in problem solving, negotiations, and collaborative team building with non-direct reports and other stakeholders.

Responsibilities

• Strategy Development: Identify, develop, and implement quality and compliance strategies across the organization, promoting advanced regulatory compliance standards.
• Inspection Readiness: Facilitate and manage cross-functional teams’ GCP inspection readiness activities throughout the study lifecycle.
• Process Embedding: Embed real-time inspection readiness strategies into daily operations, collaborating with study teams.
• Mentorship: Provide just-in-time mentorship on key operating model processes and required documentation, prioritizing real-time inspection readiness.
• Planning & Tools: Manage and guide teams on inspection readiness planning, developing and maintaining readiness plans and tools.
• Deliverables: Facilitate the development of key inspection deliverables, including functional presentations and study team preparation for audits.
• Compliance Assurance: Ensure high-quality deliverables for global studies by guiding adherence to operational processes and documentation.
• Prioritization: Champion proactive prioritization of inspection readiness, focusing on GCP process excellence.
• Collaboration: Engage with subject matter experts in inspection readiness activities and study-level risk assessments.
• TMF Management: Coordinate and manage TMF performance and processes, ensuring compliance and inspection readiness.
• Meeting Facilitation: Lead and participate in meetings for assigned projects, ensuring effective communication and addressing customer concerns.
• Documentation: Maintain project management documentation, including plans, timelines, and progress reports.
• Study Team Readiness: Coordinate activities to enable study team readiness for internal audits and regulatory inspections.
• Inspection Support: Manage functional teams during inspections, collaborate with SMEs, and ensure timely follow-up.

Application Instructions

• Not provided

Company Information

• Company: Thermo Fisher Scientific
• Industry: Healthcare Operations
• Job Focus: GCP Compliance and Process Excellence