Overview
In this role you will design and lead global Quality strategies across multiple GxP areas, focusing on risk-based QA for services, suppliers and patients. You will direct audits, inspections and regulatory interactions to demonstrate compliant operations and drive improvements. You’ll mentor peers, influence PDQ goals, and own complex quality issues from discovery to closure. This position sits at the intersection of science, compliance and cross-functional leadership, offering high-impact opportunities to shape quality at scale. Join Roche/Genentech to advance patient safety and product quality on a global stage.
Leistungen / Benefits
- discretionary annual bonus
- comprehensive benefits package
- opportunity to work on global quality initiatives
- development and mentorship
- cross-functional collaboration
Verantwortungsbereiche
- Design and implement quality strategies with risk-based approaches and stakeholder collaboration
- Independently manage complex quality issues involving service providers and suppliers, including escalation and process improvements
- Define audit programs and develop methodologies incorporating data analytics
- Perform and lead audits with preparation, execution, reporting, and action follow-up
- Draw independent quality conclusions and develop action plans for evidence of compliance
- Lead stakeholder communications on observations and compliance risks
- Prepare for and manage Health Authority inspections and train staff for inspections
- Contribute to PDQ goals, develop/ revise processes and SOPs, and mentor others
Zentrale Anforderungen
- 10+ years in pharmaceutical or related fields
- 8+ years in GCP and/or Medical Device quality assurance and auditing
- Strong knowledge of clinical/pharmacovigilance/regulatory requirements
- Proven project management and leadership experience
- Experience with cross-functional/global projects and audits
- Ability to influence, negotiate and drive results in a matrix organization
- leadership
- stakeholder communication
- analytical thinking
- GxP knowledge
- GCP
- GVP
Principal Quality Lead in Basel Arbeitgeber: Genentech
Als Arbeitgeber im Bereich Biometrie bietet Roche eine inspirierende Arbeitsumgebung, in der Innovation und Teamarbeit im Mittelpunkt stehen. Unsere Mitarbeiter profitieren von umfangreichen Entwicklungsmöglichkeiten, einem flexiblen Arbeitsmodell und einem attraktiven jährlichen Bonus, während sie an der Schnittstelle von Technologie und Gesundheitswesen arbeiten, um die Patientenversorgung zu verbessern. In unserem dynamischen Team fördern wir eine Kultur des Wissensaustauschs und der Zusammenarbeit, die es jedem ermöglicht, einen bedeutenden Beitrag zu leisten.
