Manager Product Transfer
* Requisition ID: WD166647
* Position: Full-Time Regular
* Open date: May 16, 2018 10:01 AM
* Functional area: Manufacturing
* Required degrees: Not Indicated
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- Oversight of Product Transfer projects impacting all GSK Vaccines sites and CMO's
- Lead complex projects that could have huge impact on GSK business
- Act as key contact for all GSK vaccines sites
- Participate in transfer governing bodies (Project Steering, Site Steering, Advisory Committee…)
- Prepare and manage all the meetings and documents related to the project (agenda, minutes, Team Site, TC…..)
- Lead change initiatives involving Product transfer (process harmonization, documentation, ways of working), which contributes to the overall effectiveness of the department
- Lead initiatives to improve the efficiency / ways of working of PT/ES
- Provide all technical/product information to technical partner according to the phasing defined in the project charter, focusing primarily on process but also on QC, QA, Engineering and Regulatory aspects
- Ensure the availability of all documentation required to support the transfer (BR, SOP, MOP, ….). Generate and update all necessary documents according to the transfer procedure ( URB, PTS …).
- Prepare knowledge transfer for the receiving site (training, organization visit….)
- Implement and communicate the defined harmonized transfer process
- Consolidate the progress of the individual project by monitoring the timelines. Escalate issues if appropriate
- Ensure availability of vaccine components for the different projects
- Ensure the availability and alignment of resources between both donating and receiving site.
- Liaise with Engineering Shared Services when support is requested from partner's facility design or support for custom-designed process equipment
- Help diagnosing problems and advice on possible alternatives/solutions
- Define the regulatory strategy in collaboration with the RA team
- Anticipate RA impacts of Product transfers, liaise with GSK's regulatory and product experts.
- Present the Transfer Technical package to Authorities
Why You?Basic qualifications:
- University degree in the Pharma, Life Sciences or Biotechnology field with experience in manufacturing operations of vaccines / project management (> 8/10 years)
- Scientific and technological know-how related to vaccine manufacturing (primary and/or secondary).
- Understand rules and complex regulations related to vaccines manufacturing
- Expertise in vaccine products
- Good knowledge of GSK Vaccines organization and inter relationships between all GSK Vaccines 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.
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.