Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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:
QualityJob Sub Function:
Digital QualityJob Category:
People LeaderAll Job Posting Locations:
Schaffhausen, SwitzerlandJob 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 complete, accurate, and defensible validation and lifecycle documentation for GMP-relevant computerized systems.
Coach and supervise QA SMEs, support capability building, and ensure adequate prioritization of QA resources across the CSV and digital quality portfolio.
Qualifications
A minimum of a Bachelor’s Degree is required, preferably in Pharma, Biology, Engineering, Automation, Chemistry, Biological or Food Sciences field.
A minimum of six (6) years of GMP experience in either Pharmaceutical, Medical Device is required.
Strong people leader skills
Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.
Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
Strong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.
Demonstrated skills in Process Excellence preferred.
Required Skills:
Preferred Skills:
Compliance Management, Controls Compliance, Corrective and Preventive Action (CAPA), Developing Others, Digital Assurance, Human-Computer Relationships, Inclusive Leadership, Leadership, Performance Measurement, Process Governance, Process Optimization, Program Management, Quality Control (QC), Quality Standards, Quality Validation, Regulatory Compliance, Standard Operating Procedure (SOP), Team Management