eqms management review process champion - 10035

Our client is currently implementing a new Electronic Quality Management System (Veeva Vault solution). For that reason, they are looking for a Management Review Process Champion who will play the role of Process Owner within the project. This role, fully dedicated to the project, will represent the client Corporate Process Owner(s) in place who will be one of his/her key stakeholders.

• Is a CORE member of the eQMS program with valuable and in-depth involvement in the solution creation and implementation
• Is fully dedicated to the program and is part of the project Core Team (with the IT System Owner (ITSO) and the Business System Owner (PDO))
• Represents the Process across the different entities
• Is promoting the standardization of process and data to drive the creation of harmonized processes based on the Veeva standards – key elements to reach sustainability and automation
• Builds and animates a cross-functional network of SME’s and partners with them to develop coherent and harmonized requirements
• Drives strategic alignment and decision making associated to the process change
• Is the voice of the process changes and accompany buy in towards his/her networks
• Ensures both compliance to the regulations and efficiency/sustainability of the new process designed
• Works closely with the PDO and ITSO to complete the User Requirement Specifications and supports the configuration and performs sandbox testing
• Performs the formal PQ testing
• Ensures End to End scenario testing is prepared and informal testing is executed with the SMEs
• Takes the ownership of the process documentation
• Validates the online training created
• Owns Process specific communication to the network, stakeholders and users or collaborate to global eQMS communication

• Quality generalist, minimum 3 years working in the pharmaceutical/biologics industry in a process improvement position.
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
• Must have a process improvement mindset, able to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach.
• Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
• Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
• Be capable of leading and motivating matrix teams, without direct supervision, with a substantial amount of autonomy and demonstrate professional maturity in difficult situations.
• Able to generate enthusiasm and commitment to strategic priorities.
• Must be able to effectively interact with and influence senior internal and external personnel on many aspects of process and project related matters.
• Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
• Be able to coach/train/mentor colleagues and deliver training within area of expertise.
• Must be skilled and experienced in operating across cultures and in a multi-cultural environment.
• Fluent in English and very good knowledge of French.

Consultancy

We offer an attractive salary with extra-legal advantages:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.