IT Project Quality Manager - QA e-Compliance - CSV - SOX - GxP - IT Se

IT PROJECT QUALITY MANAGER - QA E-COMPLIANCE - CSV - SOX - GXP - IT SECURITY

For one of our customers in the Pharmaceutical Industry we are looking for a IT PROJECT QUALITY MANAGER with the following:

JOB PURPOSE:

Manages the quality activities for IT projects ensuring compliance with external regulations and internal requirements.
Collaborates with IT and QA E-COMPLIANCE to ensure internal and EXTERNAL REGULATIONS are consistently addressed.
Supports global and regional projects with a variety of compliance impacts (ie CSV, SOX IT, INFORMATION SECURITY, DATA PRIVACY).
Senior member of project teams working closely with the project manager to plan, organize and create/direct quality activities and deliverables ensuring all relevant compliance requirements are met
Enforces the application of the defined project methodology for IT projects
Leads Risk Assessment sessions (FRA, ERES) according the defined procedures and processes ensuring results of the risk assessments are properly applied to associated activities.
Leads project quality reviews at defined milestones and ensures that all required activi-ties and deliverables have been completed.
Supports test activities including guidance on the development of test specifications/test execution/result evidences; Approval of Test Specifications and Test Results; Ensures the entire testing process is compliant with compliance impacts of the project.
Conducts training on relevant compliance topics (GXP/CSV, SOX IT, IT SECURITY)
Ensure completeness, consistency and management of project life cycle documentation according to relevant procedures.
Ensures compliant handover based on compliance impacts from project to support organization
Escalates quality and compliance related issues to IGM PROJECTS LEAD/PROJECT MANAGER/QA E-COMPLIANCE or others per applicable policies and procedures
Supports other related activities such as COMPLIANCE AUDITS (HEALTH AUTHORITIES, SOX IT, INTERNAL AUDITS), INTERNAL ASSESSMENTS (CSV PERIODIC REVIEWS, IT CONTROL MATURITY ASSESSMENTS)

REQUIREMENTS:

University Degree;
BA/BS in business or technical area or comparable education/experience
Minimum 3 - 5 years preferably in the Pharmaceutical Industry.
Language: English

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