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Your new company
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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HaysMaidenhead, 29 mi from Oxford
Your new company
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Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
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Salary: £55,000...
HaysMaidenhead, 29 mi from Oxford
Your new company
An innovative leader in medicine within the neuroscience therapy area is looking for a global labelling leader to join their team as a contractor.
Your new role
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Manager, Clinical Quality Assurance (Home Based / Remote)
Oxford | careers.jazzpharma.com |
Overview:
If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Position Profile:
Brief Description:
This position will lead and participate in various types of GCP/GLP compliance audits for Jazz Pharmaceuticals’ development programs including but not limited to, clinical investigator sites, service providers, and internal systems and processes globally.
In addition, this position is responsible for supporting regulatory agency inspections.
Essential Job Functions:
Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks
Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations
Collaborate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA, and monitoring successful completion of action items
Assist in managing and training external auditors ensuring compliance with Jazz Pharmaceuticals auditing standards and procedures
Provide pertinent data to support quality and compliance metrics and trending
Assist in the planning of clinical quality audit programs
Develop and maintain study specific audit plans (SSAPs) and audit certificates
Participate in strategic planning of organizational activities, as required.
Support inspection management lead to maintain Jazz R&D inspection readiness at times
Participate in regulatory agency inspection activities pertinent to R&D
Domestic and international travel is required
Qualifications
Minimum 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections
GCP audit experience is required, GVP and GLP experience is valuable but not required
Knowledge/understanding of the perspectives of regulatory agencies
Education
Bachelor’s Degree in Business or Life sciences is required, advance degree is preferred
Industry certification in Quality Assurance is preferred but not required
Competencies
Ability to manage multiple priorities simultaneously and work efficiently in a fast paced culture
Strong and clear understanding of Good Clinical Practices (GCP)
Strong knowledge of applicable global regulatory requirements
Must be disciplined, detail orientated and excel in personal time management
Collaborate and ability to interact all levels of the organization
This position requires highly diplomatic and tactful with critical reasoning skills
Strong problem solving and analytical skills
Excellent written and verbal communications skills
Ability to work independently while also supporting/working in teams collaboratively
Jazz Pharmaceuticals is an Equal Opportunity Employer.
If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Position Profile:
Brief Description:
This position will lead and participate in various types of GCP/GLP compliance audits for Jazz Pharmaceuticals’ development programs including but not limited to, clinical investigator sites, service providers, and internal systems and processes globally.
In addition, this position is responsible for supporting regulatory agency inspections.
Essential Job Functions:
Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks
Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations
Collaborate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA, and monitoring successful completion of action items
Assist in managing and training external auditors ensuring compliance with Jazz Pharmaceuticals auditing standards and procedures
Provide pertinent data to support quality and compliance metrics and trending
Assist in the planning of clinical quality audit programs
Develop and maintain study specific audit plans (SSAPs) and audit certificates
Participate in strategic planning of organizational activities, as required.
Support inspection management lead to maintain Jazz R&D inspection readiness at times
Participate in regulatory agency inspection activities pertinent to R&D
Domestic and international travel is required
Qualifications
Minimum 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections
GCP audit experience is required, GVP and GLP experience is valuable but not required
Knowledge/understanding of the perspectives of regulatory agencies
Education
Bachelor’s Degree in Business or Life sciences is required, advance degree is preferred
Industry certification in Quality Assurance is preferred but not required
Competencies
Ability to manage multiple priorities simultaneously and work efficiently in a fast paced culture
Strong and clear understanding of Good Clinical Practices (GCP)
Strong knowledge of applicable global regulatory requirements
Must be disciplined, detail orientated and excel in personal time management
Collaborate and ability to interact all levels of the organization
This position requires highly diplomatic and tactful with critical reasoning skills
Strong problem solving and analytical skills
Excellent written and verbal communications skills
Ability to work independently while also supporting/working in teams collaboratively
Jazz Pharmaceuticals is an Equal Opportunity Employer.