IT Project Quality Manager

ROLE PURPOSE
*Ensure that projects are managed and run according to our Project Methodology and to the applicable project management procedure.
*Support IT project manager quality relevant topics for assigned IT Projects.
*Ensure that the quality of processes and deliverables of projects continuously meet the specified corporate and regulatory requirements.
*Proactively work with respective IT Leadership Team and/or Business stakeholders to implement standards and policies for Information Governance and Management in Pharma

MAJOR ACCOUNTABILITIES
*Drives end-to-end quality governance in projects, including the handover to operational team.
*Responsible for application of project methodology and of local application of IGM project management procedure.
*Define and implement needs on project quality governance, establish key performance indicators and report accordingly.
*Ensure that projects execution is done in alignment with established plan, this in strict respect of methodology.
*Ensure that projects are measured (on time, on budget, on quality) and enhanced.
*Support and coach project managers in the application of methodology and of IGM project management procedure in order to deliver business solutions aligned with strategic initiatives.

For GxP relevant projects:
*Define validation approach derived from global standards and in alignment with e-Compliance Manager
*Leads validation activities including creation of Validation Plan and Validation report
*Supports the Project Manager throughout the project delivery, especially in covering compliance with the IGM Manual during project planning, execution and closure.
*Supports the Project Manager and Project Team in establishing the Quality Goals for the project.
*Supports quality/validation activities including guidance on Quality Plan/Validation Plan creation, Quality Report/Validation Report creation.
*Coaches the Project Team in fulfilling the requirements of the IGM Manual and of the Quality/Validation Plan.
*Drives the achievement of the Quality Goals by ensuring that the process and standards defined in the Quality Plan are followed by the Project Team.
*Performs tollgate reviews according to the project schedule, and escalates any critical findings/risks to the IGM Manager and project steering committee.
*Facilitates ISEC risk assessment as part of creation of the HLCD, where applicable
*Create project deliverables as identified in the Project Document Catalogue
*Support projects during internal/external inspections
*Escalates project quality issues to project team
*Reviews and Approves System Life Cycle Documentation and Test Results
*Ensure availability of project methodology and tools for the management of project deliverables
*Perform Quality Reviews at major project milestones to ensure adherence to IGM Controls and project quality plan
*Ensure completeness and consistency of system life cycle documentation

KEY PERFORMANCE INDICATORS/MEASURES OF SUCCESS
*Execution of project review (tollgates) in accordance with established planning.
*Periodic reports demonstrating that projects are delivered on time, on budget and on quality.
*A project quality support is established for assigned IT projects.

MANAGEMENT RESPONSIBILITY
*Project Management methodology
*Quality Manual
*SOX, CSV, IT InControl
*Operational methodology - ITIL
*Pharma IGM SOP's
*Pharma IGM SOP-IGM 004 Project Management

EDUCATION
Higher education, such as a degree in Information Technology and/or relevant business education
Languages:Fluency (oral and written) in English, other languages an asset

PROFESSIONAL COMPETENCIES/EXPERIENCE
*Good understanding and knowledge of business processes in a global health care industry
*5+ years of working experience, with some years with project management experience in IT
*Excellent understanding and knowledge of project management
*Knowledge of the compliance regulations (GxP/GAMP, Data Privacy).
*Experience in the validation of computerized systems
*Good understanding of Information Security, knowledge on the best practices
*Good understanding of ITIL processes (change management, incident management, etc.)
*Definition of new processes or methodologies in complex organizations
*Good understanding of commercial business processes and objectives
*Good written and verbal communication and presentation skills
*Knowledge of IT Project Methodologies (Waterfall, Agile, others an asset)
*High level of customer focus with proven problem solving skills