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Working as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.
Key Responsibilities:
To play a key role in maintaining and monitoring the GxP QMS
Job DescriptionCellular Origins Cell therapies have been shown to cure devasting and previously untreatable diseases like cancer by re-programming the patient's own immune system. Giving more patients access to these life-saving therapies requires a revolution in manufacturing and process automation.Cellular Origins, a TTP Company, is enabling scal
Cellular Origins
Cell therapies have been shown to cure devasting and previously untreatable diseases like cancer by re-programming the patient's own immune system. Giving more patients access to these life-saving therapies requires a revolution in manufacturing and process automation.
Cellular Origins , a TTP Company, is enabling scalable, cost-
m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education.
In addition, they are recognised as being one of the Top 25 Education and Training providers to work for.
As the Assistant Quality Manager at HMP Highpoint,
You will support the Assistant Manager (Quality) with effective management of the curriculum, ensuring needs of learners and employers are met, including delivery of Functional Skills, Personal & Social Development, and work-based programmes.
You will lead on quality assurance and improvement, developing and encouraging an innovative and problem-so
Have you ever considered working... in a prison?
If you would like a unique and challenging education role, where you can genuinely make a difference, enhance the prospects of your learners, and ultimately change people's lives for the better - then this could be the opportunity for you.
Like any educational setting, Prisons come with their challen
At Cellular Highways, we are on a mission to improve cell sorting based on new technology, make it accessible to every laboratory as well as enable new clinical applications. Our first product is an automated high-throughput sterile cell sorter for cell therapies. To support us with this mission, we need to find a Quality Manager to the join the te
QA Manager
£35,000 - £40,000
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I am on the lookout for a Hands-On Quality Manager to join a Food Manufacturer based in Cambridgeshire - Our client is a leading figurehead within their specific industry, with vast growth in the past year!
Within this role you will be responsible for a team of Quality Auditors, ensuring the highest sta
Job Source: MorePeople
Senior Quality Manager - GCP
Cambridge
Job DescriptionWorking as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.Key Responsibilities:To play a key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with emphasis on GCP compliance.To provide support and advice to Clinical Development teams with regards to:Definition of appropriate compliant procedures within GxP functionsManagement of quality issuesTo ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.To monitor the performance of GxP service providers with regards to the relevant quality standards.To define and manage clinical audit programme and to preform GCP audits if required.Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.Skills/Knowledge Competencies:Substantial experience of successfully managing quality issues in a biotechnology or biopharmaceutical environment.Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharmaceutical companies.Proven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including self-inspection and external audit experience.Comprehensive knowledge of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA.Basic understanding of GLP and GMP requirements for biologicsBasic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US.Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.Experience:Minimum 5+ years in a similar roleSalary and benefits:A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.