TRD QA CGT Modality Head

Role: Lead and oversee quality assurance functions within biopharma research and development, ensuring compliance with GxP standards, regulatory requirements, and internal quality systems. Primary objectives include establishing and maintaining quality management practices across clinical, preclinical, and manufacturing activities, supporting risk management, inspection readiness, and deviation management. Responsibilities encompass leading global QA teams, ensuring adherence to GCP, GLP, GMP, PV, and IP standards, facilitating audits and inspections, and managing quality issues, complaints, and regulatory submissions. Required qualifications include extensive experience in GxP quality assurance, audit and inspection management, and drug development processes, with a focus on research, clinical, and manufacturing compliance. Proven ability to lead global QA teams, manage quality risk assessments, and support regulatory readiness is essential. Candidates should possess strong knowledge of GMP, GLP, pharmacovigilance, and incident management. High-value specifics include experience with GxP systems, quality management, and compliance within biopharmaceuticals, especially in research and development, clinical trials, or manufacturing. The role is based onsite in East Hanover, NJ, with no travel specified.