Quality Control Manager - Cell and Gene Therapy
GSK has been working to develop ex vivo gene therapies for ultra-rare diseases. Having delivered on Strimvelis for the treatment of ADA-SCID, our focus is now shifting towards the development of transformational medicines in oncology and other immune disorders.
We are currently building and expanding our late phase teams to continue developing on our QC and QA teams and we now have this fantastic opportunity to join the Cell and Gene Therapy (CGT) team as a QC Manager.
Your responsibilities will be to:
• Align with CGT Analytical Development to ensure that method development, equipment and processes enable successful transfer of fit for purpose analytical methods.
• Implementation and maintenance of the quality control processes and procedures to support product development within GSK, collaborators and third parties.
• Establish systems and processes to ensure that QC procedures, systems, data and documentation follow cGMP, data integrity requirements, regulations and meet the needs of the Manufacturing and Supply processes.
• Ensure that QC Team is aligned to the requirements of the MPD process for specific projects by either acting as Analytical Workstream Lead, Analytical Workstream SME or by supporting the MPD workstream leads / members.
• Deliver GMP compliant QC data/reports through management of an internal QC team or 3rd Parties for the support of batch release and stability for critical reagents, reference materials, raw materials, cell banks, starting materials, drug substance and drug product.
• Ensure change controls, quality deviations, out of specification results and quality / business risks associated with area of responsibility are appropriately investigated, reviewed, mitigated and closed out.
• Author or review analytical data and commentary for regulatory submissions as required.
• Represent Quality Control during internal audits and regulatory inspections for area of responsibility.
If requiring an adjustment for a disability, once selected for Interview you may contact email@example.com
Closing date for applications: Friday 8th June 2018
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
• BSc or equivalent in a relevant biological science
• Experience of Quality Control for Cell and Gene Therapy or Biopharmaceutical products
• A strong understanding of and the ability to apply quality requirements, regulatory requirements and risk management to cell and gene therapy products appropriate to the stage of development.
• Working with third parties.
• Designing and implementing local quality control systems and processes.
• Qualification and Validation of Analytical methods
• Tech Transfer of Analytical Methods
• Strong organisational and communication skills
• Demonstrable ability to lead multi-disciplinary, multi-cultural teams
• Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives
• PhD or equivalent in a relevant biological science
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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