Quality Systems Lead — eQMS & GxP Training

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

Benefits offered by this job

Healthcare coverage

Health Savings Account

4 weeks paid time off

10 holidays

401k with company match

Insurance coverage including life and

Flexible spending accounts

Job summary

Cardurion Pharmaceuticals is seeking a Manager – Quality Systems to lead the QA administration of the eQMS and GxP training program. You will ensure document management compliance, develop SOPs, and support regulatory activities while partnering with cross-functional teams.

You will report to the VP – Head of Quality and work onsite in Burlington, MA three days per week, contributing to quality system development, performance monitoring, and continuous improvement initiatives.

Qualifications

• Minimum BS degree in the life sciences or a relevant discipline.
• Minimum of 5 years pharmaceutical quality assurance and GxP regulatory compliance experience.
• 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 of US/EU GxP requirements as related to document management and training.

Responsibilities

• Oversee QA administration of Cardurion eQMS and GxP Training Program.
• Develop and maintain SOPs, user guides, and training materials for eQMS.
• Support regulatory inspections through documentation preparation and retrieval.
• Collaborate with IT to implement eQMS improvements and changes.
• Provide eQMS training and guidance to system users.

Skills

Quality systems

GxP compliance

eQMS

edMS

eLMS

training administration

SOP development

regulatory knowledge

communication skills

cross functional work

Education

BS degree in life sciences

Tools

Box GxP

ZenQMS

eQMS software

Job description

Cardurion Pharmaceuticals is seeking a Manager – Quality Systems to lead the QA administration of the eQMS and GxP training program. You will ensure document management compliance, develop SOPs, and support regulatory activities while partnering with cross-functional teams.

You will report to the VP – Head of Quality and work onsite in Burlington, MA three days per week, contributing to quality system development, performance monitoring, and continuous improvement initiatives.