Senior Global PV Quality Leader

Roche; Welwyn; On-site; GBP 90,000 - 120,000; Full time

Job summary

Roche is seeking a senior PV quality leader to ensure compliance, deliver quality, and drive strategic projects across global pharmacovigilance. The role focuses on individual expertise, with no direct line management responsibilities, and involves working with GVP/GCP safety requirements to uphold the highest standards.

You will act as global process owner for PV quality, lead inspections and audits, and drive quality initiatives using data and digital tools.

Qualifications

• Deep knowledge of global GVP/GCP safety regulatory requirements.
• Excellent systems thinker and process designer.
• Experience managing health authority inspections and audits.

Responsibilities

• Act as a senior quality leader for the global PV quality organisation.
• Own license-to-operate activities, including PSMF and related requirements.
• Lead GVP and GCP safety inspections and health authority audits.
• Drive strategic quality management initiatives and safety process redesign using data and digital tools.
• Lead integration workstreams for mergers and acquisitions in safety quality.
• Collaborate across a global, matrixed organisation—safety, clinical, regulatory, and quality partners.

Skills

GVP/GCP knowledge

Job description

Roche is seeking a senior PV quality leader to ensure compliance, deliver quality, and drive strategic projects across global pharmacovigilance. The role focuses on individual expertise, with no direct line management responsibilities, and involves working with GVP/GCP safety requirements to uphold the highest standards.

You will act as global process owner for PV quality, lead inspections and audits, and drive quality initiatives using data and digital tools.