Clinical Program Quality Excellence Lead – FSP Team

🔥 12 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle • Embed real-time inspection readiness strategies into daily operations with study teams, Global Development Compliance and Clinical Quality Assurance • Guide study teams on operational process adherence and well-prepared documentation for global studies and programs • Provide just-in-time guidance on operating model processes and required documentation • Develop and maintain inspection readiness plans and tools with cQA and GCP Excellence in Clinical Trials leadership • Facilitate development of inspection deliverables, including listings, functional presentations, issue-related storyboards, and audit/inspection preparation • Action compliance monitoring signals and study health metrics to mitigate real-time issues • Engage Sponsor and CRO subject matter experts in inspection readiness and study-level risk assessments • Oversee TMF performance and processes, risk-based oversight strategies, TMF Plan and TMF Index adherence, and outsourced CRO elements • Lead and participate in Strategy Team Meetings and Lead Core Team Meetings • Communicate and escalate issues internally and externally with vendors • Maintain project management documentation, including plans, timelines and progress reports • Coordinate study team readiness for internal audits and regulatory inspections • Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses • Facilitate and monitor study-specific CAPA activities with GCP Compliance Management and QA • Identify and implement improvements in inspection readiness and study execution processes • Provide regular status updates to stakeholders and leadership • Ensure real-time alignment with functional SMEs and cQA throughout the study lifecycle and during audits and inspections

🎯 Requirements

• Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field • Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes • Experience with CROs and outsourced clinical trial activities; sponsor experience preferred • Solid knowledge of drug development and clinical trial processes, including related standards and documents • Experience in clinical trials systems management and oversight; Veeva preferred • Proven awareness of sponsor oversight requirements and regulations • Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders • Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines • Ability to work in a fast-paced, changing environment and prioritize multiple competing tasks and demands • Solid knowledge of regulatory requirements governing clinical trials and industry best practices • Bachelor's degree preferred or commensurate with experience • Ability to efficiently utilize Microsoft Office and software for general use, project management and presentations • Comprehensive understanding of the pharmaceutical industry • Advanced expertise in GCP, ICH and applicable global and local regulatory standards governing clinical research • Advanced expertise in complex Trial Master File deliverables, TMF structures and electronic document management systems, including CTMS, SSU and eTMF • Ability to learn new systems and technology quickly and provide training to cross-functional study teams • Ability to monitor, interpret and action key performance metrics, including study compliance and TMF health data • Ability to work across functions, regions and cultures • Ability to manage deliverables, lead others and drive deliverables forward

🏖️ Benefits

• Fully Remote work arrangement • Full-time employment • Standard Monday–Friday work schedule