Senior Director, GCP Quality & TA Leadership

Women In Bio; Central (PA); Vor Ort; USD 210.000 - 349.000; Vollzeit

Benefits dieser Stelle

Health care coverage

Retirement benefits

Paid holidays and leave

Zusammenfassung

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

This role is part of the Quality Business Partner Therapeutic Area Leadership Team and helps design and implement the quality strategy to ensure development programs are inspection-ready and compliant on a global scale.

Qualifikationen

• Demonstrated expertise in Good Clinical Practice (GCP) and clinical trial quality oversight.
• Experience in pharmaceutical industry and/or clinical quality assurance.
• International leadership experience with a global quality team (3+ years).
• Knowledge of quality assurance, risk management, and quality by design in clinical development.
• Familiarity with GLP, pharmacovigilance, and regulatory requirements.
• Broad knowledge in oncology, immunology, respiratory, vaccines.

Aufgaben

• Lead a team of QBPs providing GCP quality support across development and lifecycle projects.
• Drive quality strategy, risk assessments, audits, and continuous quality improvements.
• Contribute to global audit plans and rapid communication of critical quality risks.
• Support GCP inspections and regulatory interactions with health authorities.
• Develop talent, set annual goals, and manage performance within the team.

Kenntnisse

Communication

Data-Driven Decision Making

Digital Fluency

Influencing Without Authority

Problem Solving

Quality by Design

Risk Analysis

Stakeholder Management

Ausbildung

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

Tools

Veeva QMS

CTMS

Quality documentation systems

Jobbeschreibung

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

This role is part of the Quality Business Partner Therapeutic Area Leadership Team and helps design and implement the quality strategy to ensure development programs are inspection-ready and compliant on a global scale.