Manager IT Compliance

Johnson and Johnson; Schaffhausen; Vor Ort; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Digital Quality Manager to lead and coordinate QA for CSV, Data Integrity and digital quality across GMP systems. The role provides strategic and operational leadership for CSV activities, system validation, and lifecycle governance.

In close partnership with IT and business heads, you will guide QA SMEs, ensure inspection readiness, and align QA standards with regulatory expectations across local and global processes.

Qualifikationen

• Bachelor's degree in Pharma, Biology, Engineering, Automation, Chemistry, Biological or Food Sciences field.
• Minimum 6 years GMP experience in pharmaceutical or medical device sectors.
• Strong leadership in matrix organizations, collaboration across boundaries, and influencing without authority.

Aufgaben

• Coach and supervise QA SMEs, prioritize QA resources across CSV and digital quality.
• Provide QA approval and risk-based oversight for CSV strategies, requirements, risk assessments, tests, traceability, reports and release decisions for GMP-relevant systems.
• Ensure Data Integrity principles in system design, validation, operation, access, audit trails, backup and lifecycle governance.
• Provide QA input/approval for change controls, CAPAs, periodic reviews, supplier assessments, and system retirement activities.
• Establish QA standards for digital quality oversight across local and global QMS processes.
• Act as Quality representative for digital portfolio projects, laboratory system implementations, manufacturing upgrades, MES interfaces, and AI roadmap activities.
• Maintain inspection readiness with complete, accurate validation and lifecycle documentation for GMP-relevant systems.

Kenntnisse

Strong people leadership

Matrix environment navigation

Communication

Multitasking in fast-paced settings

Ausbildung

Bachelor's degree

Jobbeschreibung

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: 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 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