Quality Systems Manager
Work set-up:
Full Remote
Experience:
Mid-level (2-5 years)
Offer summary
Qualifications:
Bachelor’s Degree or equivalent research experience., At least 4 years of experience in Clinical Research and 3 years in Quality Assurance., Experience with designing, implementing, and managing enterprise eQMS solutions., Knowledge of medical terminology, research regulations, and GCP guidelines..Key responsibilities:
- Lead the design, implementation, and maintenance of the eQMS system.
- Support the Quality Assurance Department by overseeing quality and compliance activities.
- Conduct internal and external audits to ensure regulatory compliance.
- Collaborate with other departments to ensure quality standards are met.
Job description
What We Do
Care Access is a unique, multispecialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers.
Who We Are
We 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 longterm impact for generations.
Position Overview
The 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, ICHGCP 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 Youll Be Working On
Duties 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 datadriven decisionmaking.
Audit Support
· Execute the yearly audit plan, conducting both internal and onsite audits
· Conduct routine internal audits, as required, to ensure consistency and compliance with Care Access SOPs, study protocols, ICHGCP Guidelines, and other applicable regulatory requirements.
Other Responsibilities
Perform other duties as assigned. The duties listed above are representative of the nature and level of work assigned and are not necessarily allinclusive.
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 applicable
Physical 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 Bring
Knowledge, Skills, and Abilities:
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