Therapeutic Area Quality Leader — Senior Director

GlaxoSmithKline; North Carolina; On-site; USD 210,000 - 349,000; Full time

Benefits offered by this job

Health care and other insurance benefit

Retirement benefits

Paid holidays

Vacation

Paid caregiver/parental and medical le

Job summary

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

This role shapes the quality strategy, drives risk‑based improvements, supports health authority inspections, and ensures lifecycle project readiness through coaching and collaboration with global partners.

Qualifications

• Bachelor's degree or equivalent in a scientific or quality-related field.
• GCP knowledge and clinical quality oversight required.
• Experience in pharmaceutical industry and/or clinical quality assurance.
• International environment experience leading a global quality team; 3+ years supervision.
• Knowledge of GLP, pharmacovigilance and regulatory requirements.
• Experience with Veeva QMS, CTMS, and related systems.

Responsibilities

• Lead Quality Business Partners team delivering GCP quality support for development and lifecycle projects.
• Drive continuous quality improvements via risk assessments, audits, inspections, trends and root cause analysis.
• Contribute to global audit plans based on signals, trends and risks.
• Ensure rapid communication of critical quality risks and issues to business partners.
• Drive Quality by Design implementation across clinical development activities.
• Support preparation, execution and close out of health authority GCP inspections.
• Maintain awareness of international GCP/GLP/GVP regulations and internal SOPs.

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

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

This role shapes the quality strategy, drives risk‑based improvements, supports health authority inspections, and ensures lifecycle project readiness through coaching and collaboration with global partners.