Manager IT Compliance

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Digital Quality

Job Category:
People Leader

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Manager IT Compliance

The Digital Compliance Manager will lead and coordinate Quality Assurance for CSV, Data Integrity and digital quality across GxP-relevant systems and processes.

The role provides strategic and operational leadership for CSV and compliance activities throughout system lifecycle, new implementation of systems, upgrades, periodic reviews, change control, Deviations, CAPAs and inspection readiness.

The position will also supervise and guide QA subject matter experts supporting Data Integrity, CSV, digital quality systems, digital portfolio initiatives, and AI roadmap activities.

In close partnership with business stakeholders, IT leadership and functional department heads for effective realization of identified strategy and supports major programs.

Responsibilities:


* Coach and supervise QA SMEs, support capability building, and ensure adequate prioritization of QA resources across the CSV and digital quality portfolio.


* Provide QA approval and risk-based oversight for CSV strategies, user 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 ...