Senior Quality Lead - GxP, Audits & Compliance

Gi Group; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Gi Group in Basel seeks an experienced Senior Quality Lead with a strong background in pharmaceutical, biotech, or medical device industries. The role focuses on driving quality strategy, leading GxP audits, ensuring inspection readiness, and partnering with global stakeholders to uphold the highest quality and compliance standards.

The position requires at least 5 years of experience in leading GxP audits, extensive regulatory knowledge (GCP, GVP, IVD/MD, FDA/EU/ICH), and proven ability to

Qualifikationen

• Bachelor's degree in a scientific or quality-related field.
• Advanced degree preferred for higher accountability.

Aufgaben

• Develop and implement quality strategies across products, processes, and affiliates.
• Lead complex GxP audits and quality assessments.
• Present audit findings and recommendations to senior stakeholders.
• Drive continuous improvement through quality oversight and risk-based decision making.
• Lead inspection preparation and support health authority interactions.

Kenntnisse

GxP audits

Quality leadership

Stakeholder management

Regulatory knowledge

Audit management

Ausbildung

Bachelor's degree

Advanced degree preferred

Tools

Audit management systems

Jobbeschreibung

Gi Group in Basel seeks an experienced Senior Quality Lead with a strong background in pharmaceutical, biotech, or medical device industries. The role focuses on driving quality strategy, leading GxP audits, ensuring inspection readiness, and partnering with global stakeholders to uphold the highest quality and compliance standards.

The position requires at least 5 years of experience in leading GxP audits, extensive regulatory knowledge (GCP, GVP, IVD/MD, FDA/EU/ICH), and proven ability to