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Quality Systems Manager
Care AccessRemote, US, United StatesRemotefull_timeVerifiedPosted 29 Jul 2025
About the role
What We DoCare Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Who We AreWe care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position OverviewThe Quality Systems Manager is responsible for leading eQMS system design, implementation, system administration and ongoing maintenance. This role also provides support to the Quality Assurance Department through closely overseeing the quality and compliance of clinical work throughout the Company to ensure all systems and procedures undertaken are compliant with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements. With and in support of Quality Assurance Management, will coordinate and participate in specific projects and conduct activities in collaboration with other QA members. What You'll Be Working OnDuties include but not limited to:
Quality System Management· With input from key stakeholders, determine optimal workflow and configuration specifics related to electronic document management and related training, quality issues, CAPAs, audit issues and management, and reporting across all modules.· Lead the eQMS system design, implementation, system administration and ongoing maintenance.· Act as the eQMS primary system administrator, and lead for ongoing system management and maintenance.· Provide support to the Quality Department through the creation, administration and maintenance of quality systems, trackers, programs and processes.
Overall Quality Support· Track and report on quality assurance activities and metrics· Conduct reviews of Care Access procedures, as required, to ensure alignment with quality standards and regulatory requirements. · Work with other Care Access Departments to assist and provide guidance and support from a quality perspective. · Investigate, analyze, and ensure the accuracy of information in quality data collection tools, contributing to reliable data-driven decision-making.
Audit Support· Execute the yearly audit plan, conducting both internal and on-site audits· Conduct routine internal audits, as required, to ensure consistency and compliance with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements.
Other ResponsibilitiesPerform other duties as assigned. The duties listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.Work on specific projects as assigned by Quality Assurance Management
Scope of Role· Autonomy of Role: Work is performed under limited supervision· Direct Reports: No· Number of Direct Reports (if applicable):· Role(s) Managing: Not applicablePhysical Requirements· This role requires 100% of work to be performed in a remote office or clinical research site environment and requires the ability to use keyboards and other computer equipment. Travel Requirements· This is a remote position with up to 20% travel requirements. Occasional planned travel will be required as part of the role. o Type of travel required: National What You BringKnowledge, Skills, and Abilities: · Prior experience with the design, implementation, system administration, and ongoing management of an enterprise eQMS solution, including electronic document management, training, quality issues, CAPAs, audit management, and reporting functionality.· Excellent working knowledge of medical and research terminology · Excellent working knowledge of federal regulations and good clinical practice (GCP) · Attention to detail · Ability to com
Position OverviewThe Quality Systems Manager is responsible for leading eQMS system design, implementation, system administration and ongoing maintenance. This role also provides support to the Quality Assurance Department through closely overseeing the quality and compliance of clinical work throughout the Company to ensure all systems and procedures undertaken are compliant with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements. With and in support of Quality Assurance Management, will coordinate and participate in specific projects and conduct activities in collaboration with other QA members. What You'll Be Working OnDuties include but not limited to:
Quality System Management· With input from key stakeholders, determine optimal workflow and configuration specifics related to electronic document management and related training, quality issues, CAPAs, audit issues and management, and reporting across all modules.· Lead the eQMS system design, implementation, system administration and ongoing maintenance.· Act as the eQMS primary system administrator, and lead for ongoing system management and maintenance.· Provide support to the Quality Department through the creation, administration and maintenance of quality systems, trackers, programs and processes.
Overall Quality Support· Track and report on quality assurance activities and metrics· Conduct reviews of Care Access procedures, as required, to ensure alignment with quality standards and regulatory requirements. · Work with other Care Access Departments to assist and provide guidance and support from a quality perspective. · Investigate, analyze, and ensure the accuracy of information in quality data collection tools, contributing to reliable data-driven decision-making.
Audit Support· Execute the yearly audit plan, conducting both internal and on-site audits· Conduct routine internal audits, as required, to ensure consistency and compliance with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements.
Other ResponsibilitiesPerform other duties as assigned. The duties listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.Work on specific projects as assigned by Quality Assurance Management
Scope of Role· Autonomy of Role: Work is performed under limited supervision· Direct Reports: No· Number of Direct Reports (if applicable):· Role(s) Managing: Not applicablePhysical Requirements· This role requires 100% of work to be performed in a remote office or clinical research site environment and requires the ability to use keyboards and other computer equipment. Travel Requirements· This is a remote position with up to 20% travel requirements. Occasional planned travel will be required as part of the role. o Type of travel required: National What You BringKnowledge, Skills, and Abilities: · Prior experience with the design, implementation, system administration, and ongoing management of an enterprise eQMS solution, including electronic document management, training, quality issues, CAPAs, audit management, and reporting functionality.· Excellent working knowledge of medical and research terminology · Excellent working knowledge of federal regulations and good clinical practice (GCP) · Attention to detail · Ability to com
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