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Pharma Partners Recruitment Ltd
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
Job Source: Pharma Partners Recruitment LtdCellular Origins
Cambridge, England, United Kingdom
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-
Job Source: Cellular OriginsCellular Origins
Cambridge
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
Job Source: Cellular OriginsVector Recruitment Ltd
Royston
Quality Manager Cambridgeshire £50k-£70k (dep on exp) + bonus & excellent benefits! A fantastic opportunity for a Quality Manager has arisen at a Cambridge based cutting edge leading product development company whose innovative technology is reshaping the medical, life science and research sectors! The Quality Manager will be an integral membe
Job Source: Vector Recruitment LtdM2R Education Limited
Newmarket, Suffolk
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,
Job Source: M2R Education LimitedRecruited UK
Newmarket, Suffolk
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
Job Source: Recruited UKRecruitedUK
Newmarket
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-s
Job Source: RecruitedUKDovetail and Slate
Newmarket
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 chall
Job Source: Dovetail and SlateCambridge, England, United Kingdom
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 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 functions
Management of quality issues
To 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 biologics
Basic 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 role
Salary and benefits:
A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.
Senior Quality Manager - GCP jobs in Cambridge, England, United Kingdom
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