Basic qualifications: 

• Scientific university degree 
• Min 5 to 8 years experience
• Very good knowledge of written and oral French and English
• Leadership by influence capacity
• Important knowledge of manufacturing practices 
• Ability to address technical as well scientific as well business knowledge
• Good technical writing and teaching skills; good stage presence for public speaking
• Good Communication, decision making, problem solving skills
• Good company knowledge
• Good capacity to work in a cGMP environment.

Preferred qualifications: 

See basic qualifications

Details: 

Our Company: 

GlaxoSmithKline Vaccines (GSK Vaccines), the vaccine division of the GSK Group, is a global vaccine research, development and production company, at the cutting edge of innovation in the fight against the most deadly infections and diseases. Headquartered in Belgium, GSK Vaccines employs over 11,000 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux. GSK Vaccines’ global production network is in the midst of becoming the largest in the entire vaccines industry; 15 production sites strategically positioned around the world manufacture, formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.

The department: 

The Samples Management unit (+/- 30 employees) is part of the GQC Infrastructure & Lab Supply Operations department (+/- 130 employees) which report to Global Quality Control Organization of Belgian sites (+/- 650 employees).
GQC‘s vision is to test vaccines to protect Human Kind and has for mission to be a solid partner delivering global efficient and viable analytical solutions for vaccines. In this way, GQC organization supports commercial as well as development of new vaccines activities. GQC is organized by analytical competences. Physicochemistry, biochemistry, microbiology, virology, in vivo and environmental testing laboratories performs more than 1 million tests a year.
The GQC Infrastructure & Lab Supply Operations department is in charge of the management of GQC Infrastructure (4 Facilities / 15000m² effective lab surface / +/- 3000 critical equipments) in terms of preventive maintenance, periodic qualifications, validation processes, new projects ; lab supply operations (media & material preparation, supplies) ; samples management.
The QC Stability and Samples Management unit is accountable for good sampling practices for Belgian sites and responsible for: 
- Management of the storage of final container and finished products stability samples (for products in development and registered)
- Management of the logistics and supply of QC samples
- Organize reception and dispatching of samples to laboratories
- Sample qualitative and quantitative control 
- Coordinate the reorder of samples for laboratories
- Realize sample accelerated stability test for virology titration
- Manage main & back-up stocks of references, reagents & standard 
Coordinate & organize supply of references, reagents & standard to authorities, Maintain insure & develop sampling expertise at Belgian site levels with respect to local & global sops and current regulations (cGMPs, Eudralex,…)

Job Purpose and Key Responsibilities: why job exists / what it must achieve

To develop, maintain and assure the expertise linked to samples management from their picking to the delivery by:

• Guarantee the QC responsibility 
• Is responsible to identify gap between QMS documentation and GSK vaccines Belgium procedures and assure the upkeep of the samples management to the highest quality standards
• Align requirements in LSOP and assure by audit L1 that there are in use 
• Lead training session to new SOP
• Address questions coming from auditors (L2 to L4) 
• Be a referent in samples management matter: 
o be involved in new projects, 
o give advice and be involved in deviations related to samples management
o review local SOP related to samples for manufacturing building or warehouse
• Lead IT projects for increasing the samples traceability 
• Be the Single Point Of Contact (SPOC) all questions related to samples

Accountability: primary deliverables of role; it's scope; impact on strategy, policy, business or  people relationships

• Role dimension :
Influence a multiple-business & expertise’s organization.
• Transversal impact :
Ensure and optimize interfaces with: QC Labs, QA, NPD, NPI, Manufacturing, Warehouse, Global Logistics Operations.
• Business strategy: 
Implement throughout organization sampling requirement to maintain the samples management to the highest quality standards
• Staff: none, interaction with MPU SPOC, labs, and QC samples management team.
• Lead QC Samples management operations: see job purpose.
• Quality: Demonstrate commitment to the implementation of the Quality systems & operations by taking leadership, responsibility and accountability for these activities.
• Technology and process development: promote technology, process and information management systems development to improve quality, reduce risks (Security & ergonomic- samples transfer).
• Security: promote risk evaluation, preventive actions and secure behaviors. 

Complexity: degree of change & uncertainty; level of influencing required; degree of matrix working
• Degree of uncertainty & complexity:: 
High –regulatory environment, international network and interactions, prioritization between commercial, development et supportive businesses. Multiple-business & expertise’s organization. Interaction with people with diverse background and qualification level 
• Level of influence required: The incumbent must have sufficient influence to gain trust and support within QC and company to implement rapidly new projects & processes, to address any changes linked to cGMP or to solve any issues..
• Degree of matrix working: The incumbent must operate cross-functionally and be able to lead in a matrix organization; the incumbent must be able to build and sustain personal relationships with peers and subordinates to succeed; the incumbent must master roles as leader, advisor, consultant, and trainer. 
• Networking: build strong relations with other vaccines sites, in order to benchmark and stay aware of the evolution of technology.

Our Offer: CDI

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

Contact information: 

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