Quality Systems Manager

Summary

Join Care Access as a Quality Systems Manager and lead the design, implementation, administration, and maintenance of our eQMS system. You will support the Quality Assurance Department by ensuring compliance with regulations and SOPs. Responsibilities include tracking quality metrics, conducting audits, and collaborating with other departments. The role requires experience with eQMS systems, clinical research, and quality assurance. This remote position offers up to 20% travel. The ideal candidate will possess strong communication, organizational, and problem-solving skills.

Requirements

• 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 communicate and work effectively with a diverse team of professionals
• Strong Organizational Skills: Able to prioritize, delegate, direct, support and evaluate others work and follow through on assignments
• Communication Skills: Strong verbal and written communication skills as evidence by positive interactions with coworkers, management, clients and vendors
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals
• Strong computer skills with demonstrated abilities using clinical trials associated systems, electronic data capture, MS Word and Excel
• Ability to balance tasks with competing priorities
• Demonstrate effective decision-making skills
• Curiosity and passion to learn, innovate, able to communicate any possible risks and get things done
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• High level of self-motivation and energy
• Ability to work independently in a fast-paced environment with minimal supervision
• Must have a client service mentality
• Bachelor’s Degree or equivalent research experience
• 4 years of experience in Clinical Research and 3 years in Quality Assurance
• 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
• Occasional planned travel will be required as part of the role

Responsibilities

• 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
• 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
• 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
• Perform other duties as assigned
• Work on specific projects as assigned by Quality Assurance Management

Benefits

This is a remote position with up to 20% travel requirements