Quality Systems Lead, GxP & eQMS - Onsite Burlington

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

Benefits offered by this job

Healthcare coverage

401k with company match

Paid time off

Holidays

Life insurance

Disability insurance

Flexible spending accounts

Job summary

Cardurion Pharmaceuticals, Inc. in Burlington, MA. is seeking a Manager – Quality Systems to lead the eQMS administration and GxP training program within the Quality unit.

You will ensure document management and training activities comply with GxP regulations, develop SOPs, and support regulatory readiness. This onsite role requires three days per week in the Burlington office. Join a clinical‑stage company advancing cardiovascular therapeutics with a collaborative team and ongoing quality

Qualifications

• Bachelor's degree in life sciences or related discipline is required.
• Minimum 5 years pharma quality assurance experience in GxP document management and training.
• Hands-on experience administering electronic quality systems (eQMS, eDMS) preferred.

Responsibilities

• Administers Cardurion's eQMS to ensure validated state and compliance.
• Develops SOPs, user guides, training materials and delivers training to eQMS users.
• Facilitates document lifecycle (draft, review, approval, issuance) for Quality Policies and Procedures.
• Collaborates with IT to implement eQMS improvements and supports regulatory inspections.
• Tracks QSP progress and follows up on action items with owners.

Skills

Oral and written communication

Presentation skills

Cross-functional collaboration

Project management

GxP knowledge

Education

Bachelor's degree in life sciences or related discipline

Tools

Box GxP

ZenQMS

eQMS

eDMS

eLMS

Job description

Cardurion Pharmaceuticals, Inc. in Burlington, MA. is seeking a Manager – Quality Systems to lead the eQMS administration and GxP training program within the Quality unit.

You will ensure document management and training activities comply with GxP regulations, develop SOPs, and support regulatory readiness. This onsite role requires three days per week in the Burlington office. Join a clinical‑stage company advancing cardiovascular therapeutics with a collaborative team and ongoing quality