Senior Scientist- Quality Control

Basic qualifications: 

BSc or equivalent in Biotechnology, Biological Science or related discipline.
Experience in Quality Control for pharmaceuticals.GMP and quality management understanding.
Strong organisational and communication skills.
Demonstrable ability to work in multi-disciplinary, multi-cultural teams.
Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives.

Preferred qualifications: 

Experience of Quality Control for Bio-pharmaceuticals / Cell and Gene Therapies.
Experience of ownership of quality systems.
Experience of regulatory interactions and regulatory documentation.
Demonstrable ability to interact successfully with external auditors.
Auditing experience.

Details: 

In recent years, GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for Rare Diseases. We have commercialised one product (Strimvelis) and have two other late phase products. More recently, this approach has started to show similar transformational potential in the oncology field, and GSK has a significant collaboration in this area. The progression of our own portfolio together with the promise of newer gene therapy technologies creates an imperative for GSK to build an industry leading gene therapy platform. This will enable delivery of the portfolio in Rare Diseases and Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies.
The CMC capabilities for this platform are being built within the Cell and Gene Therapy platform. As part of the expansion of this platform, the team needs to increase capacity to ensure appropriate quality control of the growing portfolio ensuring efficient delivery of quality products to the patient.

Responsibility
• Product Quality and Compliance for Cell and Gene Therapy products under development and in commercial supply within GSK or at third parties.
• Ensuring local compliance with QMS, Pharmacopoeia and Regulatory Guidance.
• Authoring and managing local SOPs and quality systems.
• Continuous Quality Improvement.
• Participate in internal and external audits.

Specific accountabilities:
• Co-ordinating, Authoring  and implementing local quality systems and SOPs.
• Track compliance of GMP Operations local standard operating procedures with Quality Management System, Pharmacopoeia, Regulatory Guidance and best practice. Track and close out actions to fill any gaps.
• Maintenance of Training Curricula.
• Schedule local quality and safety inspections and track completion of actions.
• Track completion of actions from external quality audits, quality investigations, deviations and change controls.
• Tracking and close out of local risks.
• Work with representatives of the wider Cell and Gene Therapy department to ensure integration with department wide systems
• Local business administrator for electronic systems
• Own  QC Documentation system.

Excellent communication and leadership skills are required, as well as demonstrable ability to work effectively in multi-disciplinary and multi-cultural teams. The role will be based in the UK with the Cell and Gene Therapy group at Stevenage.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies required for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

If requiring an adjustment for a disability, once selected for interview you may contact ukdiversity.recruitment@gsk.com

Closing Date: 31st October 2016

*LI-GSK

Contact information: 

You may apply for this position online by selecting the Apply now button.