Global Pharmacovigilance Quality Director

Roche; Basel; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

Roche is seeking a Senior PV Quality Lead to ensure compliance and deliver quality across global pharmacovigilance activities. You will oversee key processes, drive inspections readiness, and shape safety quality strategy in a highly specialised, matrixed environment.

You will own license-to-operate activities, including the PV System Master File, and collaborate with global stakeholders to continuously improve quality and compliance across Roche’s medicines.

Qualifikationen

• Deep knowledge of global GVP/GCP safety requirements.
• Experience managing health authority inspections and audits.
• Ability to design compliant, efficient quality processes.
• Strong communicator in matrix organizations.

Aufgaben

• Act as senior quality leader for the global PV quality organisation, safeguarding compliance and quality standards.
• Own license-to-operate activities including global process ownership for the Pharmacovigilance System Master File (PSMF).
• Lead and support GVP and GCP inspections and audits, representing quality and safety.
• Drive strategic quality initiatives and safety process redesign leveraging data and digital tools.
• Lead integration workstreams for mergers and acquisitions, bringing data into the safety quality framework.
• Collaborate across global functions—safety, clinical, regulatory and quality—to influence and build consensus.

Kenntnisse

GVP/GCP knowledge

Quality management systems

Inspections & audits

Matrix leadership

Stakeholder management

Jobbeschreibung

Roche is seeking a Senior PV Quality Lead to ensure compliance and deliver quality across global pharmacovigilance activities. You will oversee key processes, drive inspections readiness, and shape safety quality strategy in a highly specialised, matrixed environment.

You will own license-to-operate activities, including the PV System Master File, and collaborate with global stakeholders to continuously improve quality and compliance across Roche’s medicines.