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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
Great News! We've discovered an exciting live job opportunity for a Manager, Clinical Quality Assurance (Home Based / Remote) position in Oxford. This job is currently open for hiring/recruiting by Jazz Pharmaceuticals, exclusively for you at UK Jobs. Feel free to download the job details here.
The work culture at Jazz Pharmaceuticals must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs Jazz Pharmaceuticals and also by visiting their official website through Google.
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Yes, we found live job(s) for Jazz Pharmaceuticals in Oxford.
Manager, Clinical Quality Assurance (Home Based / Remote) jobs are available in United Kingdom.
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The average salary range for Manager, Clinical Quality Assurance (Home Based / Remote) in Oxford varies, but the standard pay scale is rated "Standard" in Oxford. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively.
To apply for a job at Jazz Pharmaceuticals follow the application process following the "Apply Now" button at UK Jobs and also you can visit Jazz Pharmaceuticals official career page and follow their application process.
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