Senior Manager Quality Transfer External Supply
Job Purpose & Key Responsibilities:
• Accountable from Quality point of view to ensure a successful technical transfer (manufacturing and QC) between CMO, Outlicensee, JV and GSK sites
• Ensure appropriate quality oversight during technical transfer
• Ensure compliance to current GMP regulations, GSK quality standards, Continuous Process Validation and Registration dossier associated with the Transfer project
• Support the Global Regulatory to define the appropriate Regulatory Strategy associated with the project
• Prepare ,Review and/or Approve the Quality Contract and Quality Topics from main Supply agreement
• Ensure Quality Risk associated to the transfer are appropriately managed, escalated as required and transfer to commercial organization as appropriate
• Ensure strong interaction with GSK Global Product Quality and technical life cycle management teams to ensure appropriate Product Quality
• Ensure efficient handover of activity from Technical Transfer to Commercial Quality department
• University Scientific background (Pharmacist, PhD in life sciences, Bio Engineer...
• In depth knowledge of EU, US and WHO GMP and Regulatory requirements
• Willingness to work in a multicultural environment
• 10 Years of experience within Sterile Manufacturing or Biotechnological Environment in Quality, QC or Manufacturing environment
• English writing and speaking skills
• Based in Belgium
• Travel up to 33%
• Strong influencing Skills
• French understanding is a strong additional qualification
GSK - 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 External Quality Department is managing the Commercial Contract management organization (CMO) and is managing the Technical Transfer activites associated with CMO, Outlicensee and joint Venture
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. If you have a disability and require assistance during the course of the selection process, please let us know (via the cover letter or by email: firstname.lastname@example.org) so we can make suitable arrangements.
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.
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