Senior Director, GCP Quality & Therapeutic Lead

Regulatory Toolkit; Lower Providence Township (PA); On-site; USD 210,000 - 349,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Health insurance

Job summary

GSK is seeking a Team Lead, Therapeutic Area Quality (GCP/Clinical Quality) to guide a team of Quality Business Partners delivering expert GCP oversight across clinical trials and R&D programs. You will influence quality strategy, ensure inspection readiness, and drive risk-based improvements in a global environment.

The role requires strong GCP expertise, international collaboration, and leadership experience with a focus on quality by design and regulatory readiness across multiple therapeutic

Qualifications

• Bachelor's degree or equivalent in a scientific or quality-related field; education may be substituted with experience.
• 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 of 3 years supervisory/management experience.
• Knowledge of GLP, pharmacovigilance/drug safety and regulatory requirements; strong organizational and planning skills.
• Broad knowledge across oncology, immunology, respiratory, vaccines.
• Experience with quality systems and documentation in clinical development.

Responsibilities

• Lead a team of Quality Business Partners delivering GCP quality oversight across trials and R&D programs.
• Drive continuous quality improvements via risk assessments, audits, inspections, trends, and root-cause analysis.
• Contribute to global audit plans based on signals and risks.
• Communicate critical quality risks and issues to business partners and management.
• Lead Quality by Design implementation at asset level in development activities.
• Support preparation and execution of health authority GCP inspections.
• Contribute to due diligence activities as applicable.
• Develop talent, goals, and performance across the QBPs team.
• Maintain awareness of international GCP, GLP, and GVP regulations.

Skills

GCP Knowledge

Global Leadership

Quality Assurance

Audits & Inspections

Education

Bachelor's degree or equivalent in science or quality 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 delivering expert GCP oversight across clinical trials and R&D programs. You will influence quality strategy, ensure inspection readiness, and drive risk-based improvements in a global environment.

The role requires strong GCP expertise, international collaboration, and leadership experience with a focus on quality by design and regulatory readiness across multiple therapeutic