On a transversal project portfolio, coordinate and support the overall activities deployment (routine operation, field, technical support, and validation) for External Supply processes.
The job has a global reach, external suppliers are based worldwide, Europe, US & emerging markets
• Act as validation and technical Expert within ES
• Be the ES SME reference into the Manufacturing Expertise Center of Excellence (MECoE)
• Define the validation strategy to apply at the CMO and also support the evaluation team during the evaluation phase.
• To manage lifecycle validation for the international CMO portfolio.
• To support CMO to establish all maintenance and requalification programs
• Including the QC validation of equipment (IQOQ) and transversal equipment PQ (Autoclave, clean utilities, GMP washer, Incubators, thermostatic rooms,…)
• To provide the adequate training support to the CMO and SRM’s if needed.
• To define with the ES QA the adequate GMP standard and integrating the local regulations
• To support CMO for audit documentation and inspection readiness and prepare the local team (dry run) during audits
• To lead using his expertise a transversal team in case of deviation and CAPA definition related to the technical field
• To support the CMO by frequent site visits, teleconference.
• Ensure the availability of the all documentation required to support the validation.
• To approve the cornerstone documents during the transversal projects
• Liaise with Engineering Shared Services when support is requested from partner’s facility design or support for custom-designed process equipment
University degree in the Pharma and/or Biotechnology field with experience in manufacturing/primary & secondary operations of vaccines/ Project Management ( 3 to 6 years) and fluent in English
• Scientific and technological know-how related to vaccine manufacturing operations.
• Strong knowledge of aseptic operations
• Knowledge of international regulations (FDA, PIC’s, WHO, Eudralex and local cGMP)
• Good knowledge of GSK Vx organization and inter relationships between all GSK Vx departments
• Flexibility to face rapidly changing environment in vaccine development.
• Work in a matrix organization.
• Project management skills.
• Skills to report internally and externally.
• Keep scientific and technological know-how updated.
• Social skills to foster teamwork of people belonging to different organizations / departments / sites.
• Excellent communication and negotiation skills.
• Expert in some field, aseptic processes, secondary activity, packaging, primary activities
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.
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.
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.