Project IT Quality Manager

ROLE PURPOSE

*Ensure that projects are managed and run according to our Project Methodology and to the applicable IGM project management procedure.
*Support IT project manager quality relevant topics for assigned IT Projects.
*Ensures 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 aligment 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 Catalog
*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 responsibilityProject Management methodology - Methodology
Quality Manual
SOX, CSV, IT InControl
Operational methodology - ITIL
Pharma IGM SOP's
Pharma IGM SOP-IGM 004 Project Management
Financial responsibilityn/a

EDUCATION
Minimum 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
Mobility requirements: n/a

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