Lead, Therapeutic Area Quality - Global GCP

Regulatory Jobs; Upper Providence (Delaware County); On-site; USD 210,000 - 349,000; Full time

Job summary

GSK is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to guide a team of Quality Business Partners, ensuring proactive GCP quality oversight across clinical trials and R&D programs. You will contribute to a unified quality strategy and drive quality design into development projects.

The role emphasizes leadership of a global quality team, risk-based quality improvements, and collaboration with regulators to ensure inspection readiness and compliance.

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.
• Minimum of 3 years supervisory/management experience in an international environment.
• Demonstrated knowledge of GLP, pharmacovigilance/drug safety and regulatory requirements.
• Broad knowledge in oncology, immunology, respiratory, vaccines.
• Experience with Veeva QMS, CTMS and related clinical quality documentation systems.

Responsibilities

• Lead a team of QBPs that provides experienced GCP quality support for development and life-cycle projects.
• Identify and drive continuous quality improvements from risk assessments, audits, inspections, trends/metrics and root cause analysis.
• Input into global audit plan based on signals/trends/risks/gaps and communicate quality risks to management.
• Lead preparation, execution and close out of health authority GCP inspections.
• Drive Quality by Design implementation on asset level across clinical development activities.
• Support development of annual goals and objectives supporting the quality strategy.

Skills

Communication

Data-Driven Decision Making

Digital Fluency

Influencing Without Authority

Problem Solving

Quality by Design

Risk Analysis

Stakeholder Management

Education

Bachelor's degree or equivalent in a scientific or quality-related field

Tools

Veeva QMS

CTMS

Job description

GSK is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to guide a team of Quality Business Partners, ensuring proactive GCP quality oversight across clinical trials and R&D programs. You will contribute to a unified quality strategy and drive quality design into development projects.

The role emphasizes leadership of a global quality team, risk-based quality improvements, and collaboration with regulators to ensure inspection readiness and compliance.