Clinical Program Quality Excellence Lead – FSP Team

🔥 16 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 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 • 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, including 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 • Manage communication and issue escalation with internal stakeholders and 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 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 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 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 computer software programs such as Microsoft Office for general use, project management, and presentations

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume