OpQSS – Customer Incident Management – QA Senior Manager
Position Title: OpQSS – Customer Incident Management – QA Senior Manager
Working Location: Wavre
Employment Status: Full-Time Regular
Required Experience: Not Indicated
Required Education: Not Indicated
Travel Required: 0%
- Management of technical complaints for GSK vaccines worldwide (more than 120 markets) in a timely manner and define actions in order to prevent recurrence of complaints, major incidents and recalls from the market.
- Manage serious product incidents on vaccines, which may lead to product recalls and communications to authorities, by chairing the Product Incident Review Committee
- As Global Quality System Owner for Vaccines, ensure harmonization of Quality systems (Complaints and Product Incident Management) across all GSK Vaccines sites
- Lead a Team of 2 to 5 quality professionals who are responsible for managing technical complaints for GSK vaccines worldwide (more than 120 markets)
- Analyse complaint trends and manage complaints to prevent recurrence of complaints, major incidents and recalls from the market.
- Manage technical signals seen on certain batches in accordance with procedures in place, together with the Pharmacovigilance dept.
- Continually improve the Technical complaints management process
Product Incident Management
- Manage serious product incidents on vaccines, which may lead to product recalls and communications to authorities. Chairing the Product Incident Review Committee, a cross-functional and multidisciplinary team involving representatives (Directors, VPs) from different departments as Quality Labs, Regulatory, Legal, Safety, Medical, and Communications whose mission is to evaluate and decide if a batch must be recalled. Liaise with the GSK Global Recall Board and inform all official authorities involved.
- Ensure collaboration with Legal Global Trade Marks (LGTM) and Corporate Security and Investigations (CSI) in case of counterfeiting suspicion
Global Quality System Owner
- Ensure the harmonization of Complaints and Product Incident Management processes across all Vaccines Manufacturing sites (around 16 sites worldwide)
- Write/Review SOP’s related to Complaints and Product Incident Management.
- Develop training packages and train colleagues on Complaint or Product Incident Management
- Implement performance metrics; perform periodic reviews and determine the need for process improvement.
- Lead a global network, build capability of local Subject Matter Experts at the Manufacturing sites, at the GSK Local Operating Companies and in the Global Functions
- Manage, coach and develop a team of 2 to 5 persons in their daily activities
- Represent Vaccines QSS Customer Incident Management team during regulatory inspections (FDA, Japan, WHO, EMA, Belgium) or internal audits
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.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.
For further information, please visit www.gsk.com
Pharmacist or Masters in scientific orientation (Pharmacist, Biologist, etc…)
Experience in a Biologicals company (10 years)
Experience in complaints or issue management (5 years)
Knowledge of Regulatory processes – content of file, labelling variations possible
Good knowledge of products and markets/customers is an asset
Working in multidisciplinary teams
Fluent in French and English (oral and written).
Résumé des fonctionsReference Code:PCK343-330408
Job Status/Type: Full Time
Location: Wavre, Walloon-Brabant 1300
Informations de contactGlaxoSmithKline