Senior Quality Lead - Global GxP Strategy & Audits

ELAN Personal AG; Basel; Vor Ort; CHF 130.000 - 165.000; Vollzeit

Zusammenfassung

Roche Switzerland in Basel is seeking a Senior Quality Lead to guide QA strategies, audits and regulatory conclusions across development and post-approval activities. You will partner with global stakeholders to ensure GxP compliance and robust quality data for Health Authorities.

The role demands leadership in audit programs, inspection readiness, PDQ process development, and staff training, with a strong emphasis on cross-functional collaboration and delivering clear, actionable insights to

Qualifikationen

• Bachelor's degree or equivalent in a scientific or quality-related field.
• Significant experience in the pharmaceutical/biotech/medical device industry with GxP regulations (FDA, EU, ICH).
• Min. 5 years experience leading GxP audits and managing complex quality projects.
• In-depth knowledge of drug development processes and global regulatory landscapes.
• Fluency in written and spoken English; multilingual skills desirable.

Aufgaben

• Design and implement quality strategies across molecules/products/processes/affiliates.
• Lead and perform complex audits and quality assessments.
• Prepare for inspections and manage regulatory readiness with authorities.
• Drive PDQ goals and develop or revise PDQ processes.
• Foster cross-functional collaboration with global stakeholders to meet quality standards.
• Provide staff training and ensure materials for regulatory review are prepared.

Kenntnisse

QA Leadership

GxP Audits

Stakeholder management

Analytical thinking

Regulatory knowledge

Ausbildung

Bachelor's degree in scientific/quality field

Advanced degree preferred

Tools

Audit management tools

Analysis reporting tools

Jobbeschreibung

Roche Switzerland in Basel is seeking a Senior Quality Lead to guide QA strategies, audits and regulatory conclusions across development and post-approval activities. You will partner with global stakeholders to ensure GxP compliance and robust quality data for Health Authorities.

The role demands leadership in audit programs, inspection readiness, PDQ process development, and staff training, with a strong emphasis on cross-functional collaboration and delivering clear, actionable insights to