- 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.
- 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.
- Minimum 5+ years in a similar role
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Quality Manager
1 week ago
Sepura Cambridge, United KingdomFancy being part of a collaborative, forward-thinking global leader in critical communication solutions? Here at Sepura Ltd we are currently recruiting for a Quality Manager to join our expanding team. · This role will be pivotal in ensuring that Sepura's product designs are engi ...
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Quality Manager
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Sepura Cambridge, United KingdomFancy being part of a collaborative, forward-thinking global leader in critical communication solutions? Here at Sepura Ltd we are currently recruiting for a Quality Manager to join our expanding team. · The Quality Manager will lead Sepura's Quality Team and providing support an ...
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Qkine Cambridge, United Kingdom**Finance & Quality Management System (QMS) Assistant, full time.** · Location: Murdoch House (off Newmarket Road), Cambridge, UK · Reporting to the Head of Finance, this role will be responsible for providing administrative assistance to both the Head of Finance and the Quality ...
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BookBrunch Limited Cambridge, Cambridgeshire, United KingdomCambridge Literary Festival - Festival Manager · The role has a focus on logistics and delivery but has creative or development opportunities for the right candidate. · Key responsibilities will include responsibility for planning and managing all Festival operations, including ...
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Sports Technology Awards Group Cambridge, Cambridgeshire, United KingdomAbout Better Origin · Our food chain is broken - the system that can barely feed 7 billion people will not feed 10 billion we're expected to reach by 2050. And while it's hard to imagine that things could be different, they have to be. At Better Origin, our mission is to fix the ...
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TTP Cambridge, United Kingdom OTHERCellular 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 au ...
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Sports Technology Awards Group Cambridge, Cambridgeshire, United KingdomOur food chain is broken - the system that can barely feed 7 billion people will not feed 10 billion we're expected to reach by 2050. At Better Origin, our mission is to fix the broken food chain. We are inspired by nature and how it deals with waste, with nutrients always flowin ...
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Manager, Quality Management
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Gilead Sciences International, Ltd. Cambridge, United Kingdom Full timeDescription · Manager, Quality Management within Strategic Operations, Patient Safety · The Patient Safety (PS) department is a global function that is part of the Development organisation within Gilead. The main Pharmacovigilance activities of PS are centered at three sites: ...
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Customer Quality Manager
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Jenson Fisher Consulting Ltd Kempston, United Kingdom**Customer Quality Manager - Bedford** · **£24,000 per annum, with an achievable £30,000 OTE** · **8am till 6pm - Saturday by rota half day one in every 3 weeks** · Our client is a leading and successful privately owned automotive network, operating over 30 sites across London, E ...
Senior Quality Manager - Cambridge, United Kingdom - Pharma Partners Recruitment Ltd
Description
Job Description
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:
Skills/Knowledge Competencies:
Experience:
Salary and benefits:
A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.
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