Team Lead, GCP & Clinical Quality

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

Benefits dieser Stelle

Health insurance

Retirement benefits

Paid holidays

Parental and caregiver leave

Zusammenfassung

GSK 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 supports quality strategy and readiness for inspections.

The position focuses on ensuring quality by design in clinical development, risk-based QA, and regulatory compliance within an international, cross-functional environment. Strong leadership and collaboration are essential.

Qualifikationen

• Bachelor's degree in a scientific/quality field or equivalent experience.
• GCP expertise and clinical trial quality oversight.
• Experience in pharmaceutical industry or clinical quality assurance.
• International leadership with 3+ years supervising.
• Knowledge of QA, risk management, and quality by design in clinical development.
• Knowledge of GLP, pharmacovigilance, regulatory requirements; strong analytical and planning skills.
• Broad knowledge in oncology, immunology, respiratory, vaccines.
• Experience with Veeva QMS, CTMS and related systems.

Aufgaben

• Lead activities to progress QA strategy and drive changes in QuRE processes.
• Identify and drive quality improvements from audits and trends.
• Contribute to global audit plans.
• Communicate critical quality risks to stakeholders.
• Lead Quality by Design implementation across development.
• Support health authority GCP inspections and related activities.
• Develop talent and manage performance within the team.
• Maintain awareness of international GCP/GLP/GVP regs and internal policies.

Kenntnisse

Communication

Data-Driven Decision Making

Digital Fluency

Influencing Without Authority

Problem Solving

Quality by Design

Risk Analysis

Stakeholder Management

Ausbildung

Bachelor's degree

Jobbeschreibung

GSK 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 supports quality strategy and readiness for inspections.

The position focuses on ensuring quality by design in clinical development, risk-based QA, and regulatory compliance within an international, cross-functional environment. Strong leadership and collaboration are essential.