Global Quality Strategy Lead – Audits & Inspections

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 129.000 - 239.000; Vollzeit

Benefits dieser Stelle

Discretionary annual bonus

Genentech benefits package

Zusammenfassung

Genentech seeks a Principal Quality Lead to design and deliver robust Quality strategies across GxP areas, focusing on service providers and suppliers. You will lead audits, draw evidence-based conclusions, and guide regulatory interactions.

The role emphasizes data-driven QA and cross-functional collaboration across global teams. Located at Basel / San Francisco campuses, with a focus on PDQ processes and inspections readiness.

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 QA/auditing.
• Demonstrated knowledge of clinical/pharmacovigilance regulations and data analysis.

Aufgaben

• Design and implement Quality Strategies across GxP areas and risk-based QA approaches.
• Lead audits and manage reports, actions, and evidence for compliance.
• Draft quality conclusions and determine acceptability of evidence.
• Communicate observations and risks to stakeholders and regulatory teams.
• Lead inspection preparation and support regulatory authority inspections.

Kenntnisse

Quality Assurance

Auditing

GxP knowledge

Regulatory experience

Data analytics

Ausbildung

Bachelor’s degree in science/quality

Advanced degree preferred

Tools

Regulatory systems

Data analytics tools

Jobbeschreibung

Genentech seeks a Principal Quality Lead to design and deliver robust Quality strategies across GxP areas, focusing on service providers and suppliers. You will lead audits, draw evidence-based conclusions, and guide regulatory interactions.

The role emphasizes data-driven QA and cross-functional collaboration across global teams. Located at Basel / San Francisco campuses, with a focus on PDQ processes and inspections readiness.