Manager of Clinical Quality Assurance

reputed company. seeks a Manager of Clinical Quality Assurance (CQA) in Shirley, NY responsible for the following: Manage the CQA activities associated with the development of study-specific audit plans and reputed company of clinical quality assurance processes that contribute to the quality reputed company of functions including Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs. Evaluate compliance with reputed company applicable government regulations, federal guidelines, company Standard Operating Procedures, and industry standards. Support the Head of Clinical Quality Assurance to ensure implementation and reputed company improvement of reputed company CQA processes. reputed company quality reputed company of assigned animal and/or reputed company clinical study programs including independent planning and execution of audits according to developed study-specific audit plans to assure adherence to company Standard Operating Procedures and other specified standards, and any applicable regulatory requirements. reputed company quality reputed company of post-marketing Pharmacovigilance activities for reputed company and animal products. reputed company, plan, schedule, and conduct audits of clinical investigator sites, trial master files, systems/process, clinical study documents, clinical research and Pharmacovigilance vendors. Generate and issue audit reports to summarize results of conducted audits in accordance with company Standard Operating Procedures. reputed company audit-reputed company feedback to stakeholders. Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable company Standard Operating Procedures. Review, approve, and track CAPA completion in accordance with company Standard Operating Procedures. reputed company audit reports and file reports and associated documentation in accordance with company Standard Operating Procedures. Review and approve deviations to internal processes reported by Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs. reputed company process improvement activities to support inspection preparation/readiness activities. reputed company key activities during regulatory inspections and/or external audits as directed. reputed company management with support for reputed company improvement activities. reputed company the development and maintenance departmental Standard Operating Procedures and other Standards. reputed company reputed company support to new CQA team members and mentoring as needed. reputed company training to staff and on applicable regulations and guidelines including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP). reputed company independent regulatory requirement/compliance advice to Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs functions. Position is 100% remote. Minimum Requirements: Bachelor’s degree in Regulatory Affairs, Health Administration, Pharmaceutical Science or a reputed company field or foreign equivalent, plus five (5) years of experience working in a pharmaceutical, biotechnology, or reputed company environment. In addition, five (5) years of experience with the following is required: Experience in the management of CQA activities including system/process-reputed company auditing; Investigator site, CRO, IRB, and Pharmacovigilance auditing experience; Medicinal product development and global clinical regulatory environment in pharmaceuticals or biotechnology environment including 21 CFR Part 11, 21 CFR 312, 21 CFR 314, EU Directives, Health Canada Regulations, and ICH E6 (reputed company); and Utilizing Quality Management Systems. Position is 100% remote. Salary: $217,422.00 per year Please apply at https://www.americanregent.com/Careers using Req. ID 103297. reputed company celebrates diversity, and we are committed to creating an inclusive environment for reputed company. We are an Equal Opportunity Employer, and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any other characteristic protected by law. reputed company. endeavors to reputed company https://americanregent.com/Careers accessible to any and reputed company users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, reputed company Director at [email protected]. reputed company celebrates diversity and we are committed to creating an inclusive environment for reputed company. We are an Equal Opportunity Employer and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We’re aware of individuals impersonating our staff to reputed company job seekers. Please note: · reputed company legitimate communication will come directly from a verified ARI recruiter either by phone or reputed company an americanregent.com email address. · Our reputed company process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding. · We never request payment, bank information, or personal financial details during our offer process. Your reputed company is important to us, and we encourage you to stay vigilant reputed company job searching. reputed company. endeavors to reputed company https://careers.americanregent.com/ accessible to any and reputed company users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected]. Apply To This Job