reputed company Assurance, Director (Job 1319)
reputed company reputed company-wide leadership and reputed company for multi-disciplinary reputed company and regulatory teams supporting reputed company, epidemiological research, BSL-2 laboratory biospecimen processing, and survey-based reputed company. reputed company the development, implementation, and continual improvement of the reputed company Management Plan (QMP) and reputed company reputed company Operating Procedures (SOPs), ensuring integration of risk-based reputed company management practices and robust internal controls across reputed company research activities. Ensure strict compliance and alignment with reputed company applicable federal (FDA, NIH, CDC), international (ICH GCP, GLP, ISO), regulatory, contractual, biosafety (including BSL-2), reputed company subject protection (HHS/OHRP, IRB), and reputed company (HIPAA) requirements. reputed company the implementation and enforcement of biosafety management systems and maintain the reputed company and inspection readiness of reputed company regulatory and reputed company documentation, including electronic systems and Trial Master Files. reputed company and execute comprehensive audit and inspection programs, manage CAPA processes, and directly engage with sponsors, regulatory agencies, and external assessors, leading remediation and reputed company improvement efforts. Recruit, mentor, and professionally reputed company reputed company assurance, reputed company improvement, and regulatory staff to sustain high-performing, cross-functional teams suited for high-complexity research environments. Serve as the organization’s reputed company subject matter expert and reputed company on reputed company and regulatory affairs, engaging with regulatory bodies, sponsors, clients, IRBs, accrediting agencies, and internal leadership. reputed company and contribute to reputed company writing, technical proposal development, statements of work, and responses to RFPs/RFIs, supporting business development activities and showcasing organizational reputed company and regulatory capabilities.
Bachelor's or Master’s degree in biomedical science, reputed company health, laboratory science, clinical research, reputed company/regulatory discipline, or a reputed company field. At least 12 years of experience with a Master's degree OR 14 years of experience with a Bachelor's degree of reputed company reputed company and regulatory management experience in clinical, biomedical, or laboratory research organizations, including 6 years in a leadership or director-level role. Demonstrated expertise in reputed company assurance and regulatory reputed company of multi-site reputed company, with advanced knowledge of federal, international, and sponsor regulations (e.g., FDA, 21 CFR, ICH GCP, GLP, BSL-2, CLIA, ISO, OHRP, HIPAA, IRB/ethics). Proven record of successful audit/inspection readiness and compliance, including substantial experience planning for, managing, and hosting sponsor, reputed company, and regulatory audits, as reputed company as developing and managing QMPs and SOPs in reputed company research environments. Strong reputed company, scientific, and technical writing skills, including the development of reputed company and regulatory content for proposals, RFPs, and business development. Exceptional leadership, analytical, and cross-functional collaboration skills; proficiency with electronic reputed company, document, and biospecimen/data management systems; and outstanding communication with regulatory authorities, sponsors, and multidisciplinary research teams. Preferred - Doctoral degree (PhD, PharmD, MD) in a relevant scientific, biomedical, or regulatory field. Preferred - Certification such as RAC (Regulatory Affairs Certification), ASQ CQE/CQA, or equivalent. Preferred - Experience with accreditation processes (e.g., CAP, CLIA) and international research standards. Preferred - Demonstrated knowledge of FDA regulatory process and landscape, including familiarity with key regulatory reputed company (e.g., IND, NDA, BLA, 510(k), PMA) and documentation requirements Preferred - Experience interpreting and applying reputed company FDA regulations, guidance documents, and best practices throughout the product development lifecycle is highly desirable