Global Quality Strategy Lead – GxP & Audits

Genentech; Basel; Vor Ort; CHF 129.000 - 240.000; Vollzeit

Zusammenfassung

Genentech is seeking a Principal Quality Lead to shape QA strategy across GxP areas, lead audits, and manage health authority inspections. The role requires expert GCP knowledge and experience guiding service providers and suppliers.

Basel-based or regional site consideration offers global impact. You will design strategic quality plans, oversee audits, mentor junior leads, and partner with cross-functional teams to ensure compliance and continuous improvement.

Qualifikationen

• Bachelor’s degree or equivalent in scientific or quality-related field; advanced degree preferred.
• Minimum 10 years in pharmaceutical industry and/or nonclinical/clinical research/PV experience.
• Minimum 8 years in GCP and/or Medical Device quality assurance / auditing.
• Demonstrated knowledge of clinical/pharmacovigilance/regulatory requirements; analytical, organizational, planning skills.
• Project management experience with leadership and mentoring.

Aufgaben

• Design and implement Quality Strategies with risk-based approach.
• Issue management focusing on Service Providers and Suppliers; elevate issues.
• Define audits and methodology; lead data analytics usage.
• Perform and lead audits and report outcomes.
• Quality conclusions and action plans for compliance.
• Stakeholder communication; present observations to stakeholders and regulators.
• Health Authority inspections: lead or support inspections.
• PDQ goals and initiatives; develop/revise processes and SOPs.
• Expertise and mentorship; train international and senior quality leads.

Kenntnisse

GCP knowledge

Quality Assurance

Auditing

Regulatory knowledge

Project management

Ausbildung

Bachelor’s degree in scientific/quality field

Advanced degree preferred

Jobbeschreibung

Genentech is seeking a Principal Quality Lead to shape QA strategy across GxP areas, lead audits, and manage health authority inspections. The role requires expert GCP knowledge and experience guiding service providers and suppliers.

Basel-based or regional site consideration offers global impact. You will design strategic quality plans, oversee audits, mentor junior leads, and partner with cross-functional teams to ensure compliance and continuous improvement.