2 of 2 21 CFR Part 11 Jobs in Reading

industry Minimum of 2 years of experience in Risk Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯