QC Empower Solutions Lead

Our client in the pharmaceutical sector is looking for a passionate QC Empower Solution Lead. Find out how your expertise can flourish in this innovative and stimulating environment based in Braine-l'Alleud.

This is a contract as a Consultant (employee or freelance): Project starting as from March 2024 till and including 31/12/2024.

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.

Job description

As a QC Empower Solution Lead, your main tasks and responsibilities will be :

• Act as QC subject matter expert to deploy and develop Empower solutions:
• Support system deployment across QC Labs
• Continuously improve the system and propose potential new ways of working
• Ensure system compliance with regulations and regulatory expectations
• Ensure system’s audit readiness (+ data) and provide support during inspections
• Develop training program and training support for each user category
• Provide technical expertise and first line of support
• Identify, escalate, and manage associated system’s risks
• Execute and coordinate activities related to Data Integrity management system:
• Co-execute to the initial data integrity risk assessment for QC computerized system
• Co-execute and coordinate the business part of the system's periodic reviews
• Ensure follow up of mitigation plan
• Coordinate and lead the community of systems Local Key User
• Coordinate local operational activities and ensure proper deployment of global requirements
• Coordinate and execute all local projects and initiatives related to the systems
• Contribute to the systems validation through document review and through partnership with all stakeholders to build appropriate PQ test scenarios
• Actively participate and represent voice of QC into the computerized solutions governing bodies and communities (local/global key user, intra/extra site, development/commercial/IT)
• Develop and participate in an external network (with providers and other companies) to share, develop, and improve the best system’s practices
• Local Subject Matter Expert for Empower business process to ensure compliance, improvement, and efficiency in a transversal way:
• Own, manage, and maintain applicable procedures, tools, templates.
• Ensure harmonization of the process and practices at departmental level.
• Monitor process effectiveness & performance at departmental level.
• Anticipate and participate in solving issues and drive continuous improvement.
• Escalate risks and gaps at appropriate governance.
• Develop or contribute to develop the training material and deliver training material.
• Continuously improve the process and propose potential smarter ways.

As a QC Empower Solution Lead, we expect the following competencies:

Education Level:

• Master's Degree
• Ability to lead multi-functional teams, influence others, hold teams accountable, results oriented, effective at networking, able to manage complex projects and deliver according to plan.
• Must be able to manage external partners and relationships to influence partners to deliver results that the company needs
• Presentation and meeting facilitation skills
• Fluent in English and French
• Ability to identify proactively (anticipate) and address potential problems or areas for improvement and act on them in a problem-solving manner
• Act as a facilitator and coordinator.
• Change management skills.
• Business driven with a view to overall strategy.
• Strong both analytical and conceptual thinking, Business driven with a view to overall strategy.
• Able to understand and get clear picture on complex, technical and business issues
• Ability to organize the multiple requests and multiple way of request
• Strong sense of accountability and responsibility, with the ability to manage priorities
• Non hierarchical management skills, Fully self-supported, Process and results oriented, Change management skills.

Consultancy Project starting in March and ending December 2024.

For this position of QC Empower Solution Lead, 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.

A rate as a freelancer is also possible.