Risk Management Lead

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Description

• Responsible for ensuring Global Risk Management and Data Integrity Risk Management principles are implemented globally • Engage in providing support for risk processes and data integrity • Evaluate and develop a Quality Maturity Matrix aligned with FDA guidance • Develop training content on QMM approaches • Facilitate global risk assessments • Work on a project to obtain and evaluate site risk registers • Engage for global standardization of risk reporting processes • Align DI Maturity Tools and Quality Maturity Tools • Maintain the risk scoring tool • Attend Data Integrity Governance meetings • Support Regulatory Information Board with RISC activities • Update Global Governing Standards in response to regulatory changes

Requirements

• Bachelor/ Master Degree in Biochemistry, Biology, Chemistry, Pharmacy or equivalent • Proven hands-on experience in the development, implementation, maintenance of maturity matrices/risk assessments in the pharma-biotech industry • Broad work experience in QA, including skills in Risk Management and Data Integrity, CAPA and Change Control • 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) • Broad knowledge of GxP requirements (US FDA, EMA, MHRA, as examples) • Excellent English skills, both written and spoken; knowledge of additional languages is an advantage

Benefits

• Performance-related bonus • Medical and dental coverage • 401k plan • Life insurance • Short-term and long-term disability insurance • Employee assistance program • Paid time off (PTO) • More