Scaleup β’ Talent β’ Sourcing β’ Recruitment β’ Startups
11 - 50
Yesterday
Scaleup β’ Talent β’ Sourcing β’ Recruitment β’ Startups
11 - 50
β’ Responsible for ensuring Global Risk Management and Data Integrity Risk Management principles are implemented globally β’ Engage in providing support for risk processes and data integrity β’ Evaluate and develop a Quality Maturity Matrix aligned with FDA guidance β’ Develop training content on QMM approaches β’ Facilitate global risk assessments β’ Work on a project to obtain and evaluate site risk registers β’ Engage for global standardization of risk reporting processes β’ Align DI Maturity Tools and Quality Maturity Tools β’ Maintain the risk scoring tool β’ Attend Data Integrity Governance meetings β’ Support Regulatory Information Board with RISC activities β’ Update Global Governing Standards in response to regulatory changes
β’ Bachelor/ Master Degree in Biochemistry, Biology, Chemistry, Pharmacy or equivalent β’ Proven hands-on experience in the development, implementation, maintenance of maturity matrices/risk assessments in the pharma-biotech industry β’ Broad work experience in QA, including skills in Risk Management and Data Integrity, CAPA and Change Control β’ Excellent knowledge of computer systems and applications with demonstrated skills in the use of information management systems in a GxP environment (Trackwise, Document Management Systems) and related tools (Power BI, Teams, Excel) β’ Broad knowledge of GxP requirements (US FDA, EMA, MHRA, as examples) β’ Excellent English skills, both written and spoken; knowledge of additional languages is an advantage
β’ Performance-related bonus β’ Medical and dental coverage β’ 401k plan β’ Life insurance β’ Short-term and long-term disability insurance β’ Employee assistance program β’ Paid time off (PTO) β’ More
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β° Full Time
π‘ Mid-level
π Senior
π² Risk
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π‘ Mid-level
π Senior
π² Risk
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π Senior
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β° Full Time
π‘ Mid-level
π Senior
π² Risk