GxP Quality Systems Manager – eQMS & Training Lead

Cardurion Pharmaceuticals; Burlington (MA); On-site; USD 135,000 - 142,000; Full time

Benefits offered by this job

Healthcare coverage

HSA

4 weeks paid time off

10 holidays and year-end shut down

401k with company match

Life and disability insurance

Flexible spending accounts

Job summary

Cardurion Pharmaceuticals in Burlington, MA, is seeking a Manager of Quality Systems to lead GxP Document Management and the GxP Training Program on-site three days a week. Reporting to the Vice President of Quality, you will ensure the eQMS is validated, maintain SOPs, and support inspections.

This role requires 5+ years in pharmaceutical quality assurance, hands-on eDMS/eLMS/eQMS experience, and strong communication.

Qualifications

• 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, e.g., development and delivery of training presentations and development and presentation of management reports on Quality System performance.
• Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.

Responsibilities

• Administers the Cardurion eQMS to ensure validated state and compliance.
• Develops SOPs, user guides, training materials; provides training.
• Facilitates document lifecycle (draft/review/approval/issuance) in the eQMS.
• Optimizes document management processes for GxP compliance.
• Collaborates with IT to implement eQMS changes.
• Supports regulatory inspections with document prep and retrieval.
• Keeps current on GxP documentation and training trends.

Skills

eQMS training

Communication

Presentations

Project management

Cross-functional collaboration

Education

BS degree in life sciences

Tools

Box GxP

ZenQMS

eDMS

eLMS

eQMS

Job description

Cardurion Pharmaceuticals in Burlington, MA, is seeking a Manager of Quality Systems to lead GxP Document Management and the GxP Training Program on-site three days a week. Reporting to the Vice President of Quality, you will ensure the eQMS is validated, maintain SOPs, and support inspections.

This role requires 5+ years in pharmaceutical quality assurance, hands-on eDMS/eLMS/eQMS experience, and strong communication.