Digital Compliance Leader: QA, CSV & Data Integrity

Johnson & Johnson; Schaffhausen; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Digital Compliance Manager to lead QA for CSV, Data Integrity and digital quality across GxP-relevant systems.

You will partner with IT leadership and business heads to implement strategies, oversee lifecycle governance, change controls, CAPAs and inspections. The role emphasizes people leadership and cross-functional collaboration, driving inspection readiness and continuous improvement.

Qualifikationen

• A minimum of a Bachelor’s Degree is required, preferably in Pharma, Biology, Engineering, Automation, Chemistry, Biological or Food Sciences field.

Aufgaben

• Coach and supervise QA SMEs, prioritize QA resources across the CSV and digital quality portfolio.
• Provide QA approval and risk-based oversight for CSV strategies, requirements, risk assessments, test documentation, traceability, reports, and release decisions for computerized laboratory and manufacturing systems.
• Ensure Data Integrity principles are embedded in system design, validation, operation, access management, audit trail review, backup, archiving and lifecycle governance.
• Provide QA input and approval for change controls, change impact assessments, non-conformances, CAPAs, periodic reviews, supplier assessments, and system retirement activities.
• Establish and harmonize QA standards for digital quality oversight across local and global QMS processes, ensuring consistent application of internal procedures and external regulatory expectations.
• Act as Quality representative for digital portfolio projects, laboratory system implementations, manufacturing equipment upgrades, automation initiatives, MES interfaces, and AI-related roadmap activities.
• Maintain inspection readiness by ensuring complete, accurate, and defensible validation and lifecycle documentation for GMP-relevant computerized systems.

Kenntnisse

People leadership

GMP experience

Matrix environment

Communication skills

Fast-paced work

Process Excellence

Influence without authority

Cross-functional collaboration

Ausbildung

Bachelor’s Degree

Jobbeschreibung

Johnson & Johnson is seeking a Digital Compliance Manager to lead QA for CSV, Data Integrity and digital quality across GxP-relevant systems.

You will partner with IT leadership and business heads to implement strategies, oversee lifecycle governance, change controls, CAPAs and inspections. The role emphasizes people leadership and cross-functional collaboration, driving inspection readiness and continuous improvement.