Consultancy Project from 03/2025 to 03/2026
Embark on an exceptional adventure with a global biopharmaceutical company, driven by an unwavering passion to meet the crucial needs of people affected by serious diseases.
Main tasks:
• Provide stewardship and functional management to lead the implementation of strategies for all the company.
GxP and non-GxP QA processes. (Veeva Source Quality QMS, …)
• Be the process data owner for Source QMS (Veeva Source Quality QMS). Ensure the use of the
platform on a global basis in collaboration with other Quality groups and applicable business areas.
Ensure that the platform is maintained in a state of compliance (validation, current procedures, etc.).
• Take a leadership role in bringing together the QMS key users on a periodic basis.
• Accountable for the inspection and audit readiness of the platform under the scope of the Quality Digital
industrialization team.
• Monitor industry trends & directions and discuss possible impact on internal strategies.
• Drive long term strategic planning for platform under scope of the Quality Digital industrialization in
collaboration with stakeholders.
• Proactively seek for continuous improvement and develop and share best practices solutions and
processes in terms of organization, positive attitude, harmonized work style and customer focus
• Establish and build a network with the companythe company key stakeholders and external partners in relation to Quality
Systems.
• Responsibility and accountability to maintain and enhancing transversal cooperation between Business
process Owners, Digital industrialization team, IT and/or Vendor.
• Act as a facilitator and contributor for the definition of global communication needs for the different
owned systems.
• Establish and develop KPIs and metrics is collaboration with the Quality Dashboarding responsible.
• Write, review and/or approve as appropriate SOPs, Change Control, Complaints, Deviations,
Investigation, and/or CAPA, trainings as they relate to the computerized system in charge.
Typical day:
- Continuous system improvement; main point of contact to ensure that the business succeeds in using the program.
- Be the process data owner for Source QMS.
- Accountable for the inspection and audit readiness of the platform under the scope of the Quality Digital Industrialization team.
- Monthly basis: Meeting with IT.
Skills :
• English is mandatory, french is a plus
•5 or more years of experience in administration or maintenance of electronic Quality management system or comparable electronic tools in the biosciences or pharmaceutical industry.
• Knowledge of GxP principles of the ICH Guidelines and
FDA regulations.
• Good knowledge of validation requirements for computerized systems in the pharmaceutical environment
• In-depth knowledge of QMS processes (complaints, deviations, audits…etc)
• Project management skills and experience
• Service oriented
• Basic knowledge of reporting tools (PowerBI, Qlik ,sense...etc)
• Knowledge of Veeva Source QMS configuration is a plus
For this position of Quality Process Data Owner, we offer an attractive salary with the following benefits :
* Work life balance
* Group insurance
* Hospitalization insurance
* 7 euros meal voucher per day
* Reimbursement km or company car
* Monthly allowance (80 euros net per month)
* A 13th month
* Training to stay at the forefront of innovation
A rate as a freelancer is also possible.