Therapeutic Area Quality Team Lead (GCP)

GSK; Collegeville (PA); On-site; USD 210,000 - 349,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Job summary

GSK is seeking a Team Lead, Therapeutic Area Quality to guide a team of Quality Business Partners providing independent GCP quality oversight across clinical trials and R&D programs.

This role sits on the Quality Business Partner Leadership Team, shaping quality strategy and ensuring that quality is designed into development programs and that submission/inspection readiness is maintained. Strong leadership in an international environment is required.

Qualifications

• Bachelor’s degree in a scientific or quality-related field or equivalent.
• Expertise in Good Clinical Practice (GCP) and clinical trial quality oversight.
• Experience in pharmaceutical industry and/or clinical quality assurance.
• Global leadership experience and minimum 3 years supervisory/management.
• Knowledge of QA concepts, risk management, and quality by design in clinical development.
• Understanding of GLP, pharmacovigilance, and regulatory requirements.
• Broad knowledge across oncology, immunology, respiratory, vaccines.

Responsibilities

• Lead a team of QBPs delivering GCP quality support across trials.
• Oversee quality strategy design and alignment with regulatory needs.
• Drive continuous quality improvements via risk assessment, audits, and metrics.
• Support health authority inspections and due diligence activities.
• Communicate critical quality risks swiftly to partners and management.

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 to guide a team of Quality Business Partners providing independent GCP quality oversight across clinical trials and R&D programs.

This role sits on the Quality Business Partner Leadership Team, shaping quality strategy and ensuring that quality is designed into development programs and that submission/inspection readiness is maintained. Strong leadership in an international environment is required.