IT PROJECT MANAGER QUALITY SYSTEMS/ PHARMA - M/F
Must-have:Senior
Machine translation — original language: French.Show original
Description :
The IT Project Manager – Quality Systems M/F supports, configures, and manages updates for the IT systems supporting Quality business processes.
He/She is responsible for the proper functioning and continuous improvement of the systems within their scope, in full compliance with Good Pharmaceutical Practices as well as the budget.
THEIR ACTIVITIES INCLUDE, BUT ARE NOT LIMITED TO:
- Maintaining operational excellence for all systems within their scope,
- Incident resolution,
- Configuration of new functionalities,
- Managing relationships with users as well as with the solution provider, in order to resolve problems related to system usage and to meet new business needs,
- Managing updates for the various systems within their scope.
DAILY ACTIVITIES:
- Managing the administration of the systems within their application scope (Ennov Doc, Ennov Training, Ennov Dossier, Avanteam QMS…),
- Managing system access (creation, deactivation, modification),
- Taking charge of incident resolution,
- Leading the user community,
- Providing users with technical support for IT problems,
- Developing business cases including analyses such as return on investment (ROI).
LIFECYCLE MANAGEMENT:
- Monitoring IT validation activities within their application scope,
- Supervising continuous improvement to maintain and increase user satisfaction - in accordance with the DDSI department strategy,
- Driving the evolution of systems within their scope (Change Advisory Board, analysis and prioritization of change requests, Data management...),
- Participating in the annual events of our service providers.
PROJECT MANAGEMENT:
- Managing deployment and upgrade projects, as well as stakeholders, while respecting the schedule and budget,
- Selecting project participants,
- Developing or updating project plans for IT projects, including information such as project objectives, technologies, systems, specifications, schedules, funding, and the team,
- Meeting all stakeholders (department heads, senior leadership, suppliers…) to align on company challenges and context, solicit cooperation, and resolve issues.
- Performing technology monitoring in their field of activity.
Profile sought:
This function requires an Engineer, Master's, or Bac+4/5 level education, with a minimum of 5 years of experience, including at least 3 years in a similar position.
In-depth knowledge of project management, including its financial dimension,
- Knowledge of the pharmaceutical sector, including knowledge of the regulatory context of the pharmaceutical industry (GxP),
- Knowledge of quality processes,
- Proficiency in English.
- Ability to evaluate processes/solutions to improve performance and promote continuous improvement,
- Corrective and evolutionary maintenance of IT systems,
- User support.
- Responsibility, reliability, and ability to meet deadlines,
- Proactivity,
- Ability to question assumptions, open-mindedness, and active listening,
- Ability to collaborate and build an effective network inside and outside the company,
- Ability to impact and influence.
- ITIL
- PMBOK
- RGPD
- GxP
- Gamp 5 and 21 CFR Part 11