Therapeutic Area Quality Lead — GCP Oversight & Strategy

GSK plc; Durham (NC); On-site; USD 210,000 - 349,000; Full time

Job summary

GSK plc is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to oversee a team of Quality Business Partners providing independent quality oversight across clinical trial conduct and R&D programs.

The role focuses on ensuring quality is designed into development programs, defining activities for submission and inspection readiness, and driving continuous quality improvements in a global, matrix environment.

Qualifications

• Bachelor's degree or equivalent in a scientific or quality-related field.
• Demonstrated expertise in Good Clinical Practice (GCP) and clinical trial quality oversight.
• Experience in pharmaceutical industry and/or clinical quality assurance.
• Experience leading a global quality team; minimum 3 years supervisory/management experience.
• Knowledge of GLP, pharmacovigilance/drug safety and regulatory requirements.
• Broad knowledge in oncology, immunology, respiratory, vaccines.

Responsibilities

• Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet changing needs, regulatory requirements, and industry best practices.
• Identify and drive continuous quality improvements based on risk assessments, audits, inspections, trends/metrics and root cause analysis.
• Provide input into global audit plan based on signals/trends/risks/gaps.
• Ensure rapid communication of critical quality risks and issues to business partner and QuRE management.
• Lead Quality by Design implementation on an asset level across clinical development activities.
• Support preparation, execution and close out of health authority GCP inspections.

Skills

Communication

Data-Driven Decision Making

Digital Fluency

Influencing Without Authority

Problem Solving

Quality by Design

Risk Analysis

Stakeholder Management

Education

Bachelor's degree in science/quality

Tools

Veeva QMS

CTMS

Job description

GSK plc is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to oversee a team of Quality Business Partners providing independent quality oversight across clinical trial conduct and R&D programs.

The role focuses on ensuring quality is designed into development programs, defining activities for submission and inspection readiness, and driving continuous quality improvements in a global, matrix environment.