Therapeutic Area Quality Lead – GCP Excellence

GlaxoSmithKline; Philadelphia (Philadelphia County); On-site; USD 210,000 - 349,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation

Job summary

GlaxoSmithKline is seeking a Team Lead, Therapeutic Area Quality (GCP / Clinical Quality) to lead a team of Quality Business Partners providing independent GCP oversight across clinical trials and R&D programs.

You will drive the quality strategy, ensure readiness for inspections, and mentor QBPs to deliver on regulatory requirements while maintaining the highest standards of quality in diverse therapeutic areas.

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.

Responsibilities

• Lead a team of Quality Business Partners providing GCP quality oversight.
• Drive quality strategy and plan aligned with regulatory requirements.
• Ensure rapid communication of critical quality risks and issues to stakeholders.
• Support regulatory inspections and health authority readiness.
• Mentor and develop team members to meet strategy objectives.
• Maintain expertise in international GCP, GLP and GVP regulations.

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

GlaxoSmithKline is seeking a Team Lead, Therapeutic Area Quality (GCP / Clinical Quality) to lead a team of Quality Business Partners providing independent GCP oversight across clinical trials and R&D programs.

You will drive the quality strategy, ensure readiness for inspections, and mentor QBPs to deliver on regulatory requirements while maintaining the highest standards of quality in diverse therapeutic areas.