Quality & Process Leader, Clinical Operations

Roche; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Roche is seeking a Quality & Process Partner in the pRED Clinical Operations group to guide quality and process optimization across studies, audits, and inspections. You will drive CAPA, risk assessment, and continuous improvement, collaborating with global teams to ensure GCP/GVP compliance.

You bring deep experience in pharmaceutical quality, process management, and regulatory requirements, with a university life sciences background. International travel may be required.

Qualifikationen

• University degree or equivalent years of experience, preferred focus in life sciences.
• Extensive experience in pharmaceutical/healthcare industry and drug development.
• Strong knowledge of GCP/ICH and worldwide regulatory requirements.
• Proven ability to lead quality and process improvements and CAPA activities.
• Experience with risk management tools within the clinical quality framework.

Aufgaben

• Provide strategic oversight on quality issues arising from pRED studies and ensure action plans are implemented.
• Act as content expert for Quality & Processes across pRED Clinical Operations and DTAs.
• Support HA inspections and internal audits, including CAPA activities.
• Develop and execute continuous improvements related to processes and findings.
• Maintain metrics for quality and productivity; align QMS with global standards.
• Collaborate across Roche chapters and enterprise to ensure fit-for-purpose processes.

Kenntnisse

Quality management

Process improvement

GCP/ICH knowledge

Regulatory compliance

Project management

Ausbildung

University degree in life sciences

Tools

Six Sigma

LEAN

Value stream mapping

Modeling & simulation

Jobbeschreibung

Roche is seeking a Quality & Process Partner in the pRED Clinical Operations group to guide quality and process optimization across studies, audits, and inspections. You will drive CAPA, risk assessment, and continuous improvement, collaborating with global teams to ensure GCP/GVP compliance.

You bring deep experience in pharmaceutical quality, process management, and regulatory requirements, with a university life sciences background. International travel may be required.