Quality Systems Manager

Cardurion Pharmaceuticals

. Execute requirements of Cardurion Quality Systems for GxP Document Management and the GxP Training Program .

Posted 10/13/2026full-timeBurlington • Massachusetts • United StatesMid-LevelSenior💰 $135,000 - $142,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP Document Management and GxP Training Program administration, ensuring compliance with regulatory requirements while developing and maintaining quality system documentation and training materials. Proficient in managing electronic quality management systems and providing effective training and support to users.

Highest-signal resume keywords

GxP Document ManagementEQMS AdministrationSOP DevelopmentRegulatory ComplianceTraining Program Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmaceutical Quality AssuranceGxP Regulatory ComplianceDocument ManagementTraining Compliance ReportingStandard Operating Procedures (SOPs)User Guide DevelopmentData IntegrityQuality Systems ManagementEDMS AdministrationELMS Administration

Soft Skills

Strong Oral CommunicationWritten CommunicationPresentation SkillsCollaborationProject Management

Tools & Technologies

Box GxPZenQMSEQMSEDMSELMS

Industry Keywords

GxPLife SciencesPharmaceutical Quality SystemsRegulatory InspectionsQuality System Policies

About the role

Key responsibilities & impact

Execute requirements of Cardurion Quality Systems for GxP Document Management and the GxP Training Program
Support development, implementation, and maintenance of Cardurion Quality Systems
Facilitate development, review, approval, issuance, and maintenance of Quality System Policies and Procedures
Provide technical and administrative support for eQMS users
Administer the GxP Training Program through the eQMS, including training curricula management and training compliance reporting
Serve as internal subject matter expert for GxP Document Management and GxP Training
Ensure eQMS remains validated and compliant with documentation management requirements
Develop and maintain SOPs, work practices, user guides, and training materials
Train and troubleshoot for eQMS users
Support document lifecycle activities and optimize document management processes
Manage eQMS changes and functionality improvements in collaboration with Information Technology
Fulfill GxP documentation requests and support regulatory inspections
Monitor regulatory and industry requirements and trends
Develop management reports for training compliance
Collaborate with functional managers to develop and maintain role- or department-based training curricula
Track the Quality Systems Plan and follow up on action items
Support functional managers in developing SOPs and work practices

Requirements

What you’ll need

Minimum BS degree in the life sciences or a relevant discipline
Minimum of 5 years pharmaceutical quality assurance and GxP regulatory compliance experience in support of GxP document management and GxP training programs
Hands on experience in administration of electronic document management systems (eDMS), electronic learning management systems (eLMS), and/or electronic quality management systems (eQMS)
Experience with administration of Box GxP and ZenQMS software required
Working knowledge in the application of the US and EU GxP requirements as related to document management, training program administration, data integrity, and pharmaceutical quality systems
Strong oral and written communication skills
Ability to effectively provide eQMS training and guidance to system users
Ability to prepare standard operating procedures, work practices, and user guides related to the administration of Document Management and Training Quality System requirements
Oral and presentation skills to address colleagues at all levels of the organization
Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment

Benefits

Comp & perks

Healthcare coverage including medical, dental and vision
Fully funded Healthcare Savings Account for high-deductible PPO Plan
4 weeks paid time off annually
10 company paid holidays and year-end shut down
401k (traditional and Roth offered) with company match
Cardurion-paid life insurance
Cardurion-paid short-term disability insurance
Cardurion-paid long-term disability insurance
Flexible spending accounts for medical and dependent care expenses