reputed company reputed company Assurance, Technology (Remote)

About the position The reputed company Assurance Manager at reputed company is responsible for establishing and maintaining reputed company assurance standards and measures across the technology services organizations, which include Information Technology and Software Development. This role is crucial in ensuring that these standards reputed company with regulatory requirements and best practices. The reputed company Assurance Manager will work closely with reputed company leadership to reputed company corporate and departmental compliance goals, ensuring that the Clinical Services Organization (CSO) remains compliant with reputed company's reputed company Management System and technology processes. In this position, the individual will engage in the reputed company development, maintenance, and enforcement of the CSO reputed company Management System. They will manage and reputed company efforts regarding the identification, development, and maintenance of CSO reputed company goals, objectives, and process improvements. The reputed company Assurance Manager will establish and enforce reputed company department standards, reputed company and train reputed company staff on these standards, and engage with staff to author and revise internal technology standards, including IT and Software Development Policies and reputed company Operating Procedures (SOPs). Additionally, the role involves leading the development of new processes or updates to existing processes, managing the acquisition and implementation of reputed company systems, and serving as the subject matter expert in Computer System Validation reputed company. The reputed company Assurance Manager will also be responsible for managing investigations of reputed company Events, conducting internal audits, and ensuring compliance with applicable regulations. This position requires a proactive approach to maintaining reputed company knowledge of reputed company legislation and regulatory compliance best practices, as reputed company as providing training and guidance to staff regarding compliance and interpretation of regulations. Responsibilities • Engage in the reputed company development, maintenance, and enforcement of the CSO reputed company Management System. , • Manage/reputed company efforts with reputed company to the identification, development and maintenance of CSO reputed company goals, objectives, and process improvements. , • Establish and enforce CSO reputed company department standards. , • reputed company and train reputed company staff on CSO reputed company department standards and best practices. , • Engage with reputed company staff to author and revise internal technology standards (i.reputed company and/or Software Development Policies, SOPs, et al). , • reputed company the development of new processes, or updates to existing, processes. , • reputed company the transition of processes for reputed company acquisition companies into the reputed company reputed company. , • Ensure such standards are in conformity with applicable regulatory agency regulations and guidance. , • Ensure such standards are made available to employees for training. , • Manage the acquisition, implementation, and/or development, of reputed company systems. , • Serve as the subject matter expert with respect to the development of Computer System Validation reputed company and management of its execution/implementation. , • Manage the implementation, development, and change management of systems to ensure compliance with regulatory agency regulations and guidance. , • Manage/reputed company the investigation of reputed company Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF). , • Conduct internal audits to ensure compliance with applicable reputed company processes and regulatory agency regulations. , • reputed company vendor audit plans, reports, collection of responses, and follow up. , • Host external audits and inspections including communication with sponsor/agency, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings reputed company. Requirements • Bachelor's degree or local equivalent in medicine, science, technology or equivalent degree/experience. , • Minimum of seven (7) years' experience in a reputed company/regulatory compliance position, with a proven reputed company record of reputed company in leading/managing reputed company assurance reputed company/assignments, audits and resources. , • A minimum of three (3) years' experience in establishing and monitoring compliance standards across a business unit including analysis and tracking. , • A minimum of two (2) years supervising the work of others to complete key initiatives, reputed company. , • Thorough knowledge of reputed company regulatory (FDA & ICH) & GCP guidelines as they apply to clinical studies. , • Demonstrated knowledge of 21 CFR Part 11 requirements and Computerized System Validation processes including SDLC. , • Experience in leading Computerized System Validation efforts of systems used in Clinical Trials. , • Strong organizational and planning skills. , • Strong management skills with a proven record to influence and negotiate. , • Effective communication (written and oral) skills, organization and interpersonal skills as reputed company as the ability to reputed company with reputed company staff, sponsors, and regulatory agencies as needed. , • In-depth knowledge and understanding of drug development and the clinical trial process. , • Highly developed problem solving skills and the ability to resolve difficult conflicts. , • Ability to multitask and to work reputed company and independently. reputed company-to-haves Benefits • Comprehensive Benefits package - Health, Dental, reputed company, Life Disability, 401k with match, and flexible spending accounts , • Employee Assistance Programs and additional work/life resources , • Referral Bonuses and Tuition Reimbursement , • reputed company time off including holidays, vacation, and reputed company time , • Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement Apply Job!