gxp data integrity project lead 14248

The GxP Data Integrity Project Lead is responsible for improving the document management process so that it continuously meets the evolving requirements in terms of GxP Data Integrity.

Collaborating with the various global functions (Global QA, GMP Automation, GMP Internal Manuf., QCand Global IT etc.), and leveraging the experience from both the manufacturing site, clinical trial supply and supply chain, the GxP Data Integrity Project Lead will be responsible to lead the development and timely roll- out of a digital solution to manage critical GMDP forms at both global and local level driving for endto-end digitalization of processes.

In addition, the GxP Data Integrity Project Lead will also provide additional support to other Data Integrity-related topics as required (e.g., reconciliation, destruction, archiving, Quality System Monitoring Report, Corporate SOP Revision etc…)

• Project management
• Change management 
• Quality operations

The requirement for this position as GxP Data Integrity Project Lead are : 

• Proficient in GxP Data Integrity requirements in the pharmaceutical industry
• Strong organizational skills
• Excellent time management
• Excellent communication skills, including verbal, written, and presentation development and delivery (English is a must)
• Ability to influence stakeholders/project teams on whom there is no direct authority
• Analytical skills to be able to manage complex issues into more manageable individual tasks
• Prioritization skills and stress management to cope up with the various issues that may occur
• Ability to communicate on the issues with various level of the organization (from expert discussions to senior management update)
• Functions effectively with minimal supervision and in a proactive approach
• Facilitator, influencer, motivator, and planner
• Prior experience and understanding of project management principles
• Ability to work in transversal and cross-functional teams
• Sufficient level of Quality and/or Technical GxP background and to be able to evaluate complex project risks and issues accurately and objectively
• Prior knowledge of systems such as Trackwise and Veeva is an asset
• Fluent English/French

We offer an attractive salary with benefits (car, insurance, monthly allowance, 7 euros meal voucher per day, ...).  A rate as freelancer is also possible.