Director of Quality Control
- London
- Permanent
- Compliance / Quality Assurance
This vacancy has now expired
Our growing Biopharmaceutical client who are seeking to deliver truly innovative, life-changing therapies for their patients are looking for someone to fill the role of Quality Control Director. Their vision as a company is to be a major global biopharmaceutical player bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases.
This Director level role will be accountable for the development of analytical methods to support process development and enable QC release testing of the client’s products and will be responsible for leading, developing and growing the Analytical Group.
Key Responsibilities:
- Leadership of the analytical group with responsibility for the development of an analytical platform to support process/product development and provide initial QC release testing of clinical trial material across our client’s product portfolio
- Development of relevant technology platform solutions (e.g. PAT) in partnership with third parties
- Development and execution of a sound strategy to develop and grow the analytical group in line with the company’s business plan
- Close collaboration with other teams to ensure process development and manufacturing strategies, targets and ways of working are fully aligned
- Visible and credible external engagement (incl. academic groups, CMOs etc.) to support company deliverables
- Oversee and manage the release testing of vectors and plasmids through close collaboration with our CMOs
- Technical leadership and input to the regulatory strategy regarding analytical method development and QC release
- Technical review of regulatory documentation (INDs, IMPDs etc.) and participation in engagement with regulatory bodies such as the EMEA and FDA.
- A talented and highly motivated individual with significant analytical development and/or QC experience in cell & gene therapy.
- Someone that has a solid understanding of the cross-functional CMC requirements to develop and manufacture new cell & gene therapy products as well as demonstrated innovative thinking and milestone delivery in this space.
- Director/Associate Director level.
The candidate must have the rights to work in the location stated in the job advert.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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Andy
I manage this role.