Global Clinical QA Program Lead

Johnson & Johnson Innovative Medicine; Allschwil; Hybrid; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Allschwil, Switzerland, is seeking a Manager, Clinical QA Program Lead to drive GCP audits and shape audit strategies across therapeutic areas. The role requires onsite presence three days per week and collaboration with cross‑functional teams.

You will lead audit execution, oversee CAPAs, and ensure compliance with regulatory requirements, reporting to the Quality Assurance function. A bachelor’s degree and 5+ years in GxP or R&D compliance are expected.

Qualifikationen

• Requires at least 5 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP-regulated discipline).
• Experienced in conducting GCP audits.
• Experienced in developing audit strategies and capabilities for applicable therapeutic program level(s), GCP System, and/or GCP Supplier audits.

Aufgaben

• Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits.
• Monitors audit outcome trends and identifies opportunities to enhance audit strategy and overall quality and compliance of clinical programs.
• Independently leads and manages domain-specific compliance audit programs, planning, conducting and reporting QA audits.

Kenntnisse

GCP audits

Audit strategy development

Regulatory compliance

Ausbildung

Bachelor’s degree

Jobbeschreibung

Johnson & Johnson in Allschwil, Switzerland, is seeking a Manager, Clinical QA Program Lead to drive GCP audits and shape audit strategies across therapeutic areas. The role requires onsite presence three days per week and collaboration with cross‑functional teams.

You will lead audit execution, oversee CAPAs, and ensure compliance with regulatory requirements, reporting to the Quality Assurance function. A bachelor’s degree and 5+ years in GxP or R&D compliance are expected.