Senior Director, GxP QA Systems: Lead First-in-Class Therapy

Candel Therapeutics; Needham (MA); Hybrid; USD 258,000 - 280,000; Full time

Job summary

Candel Therapeutics, a biopharma company, seeks a seasoned Quality Systems leader in Needham, MA. The role focuses on GxP systems ownership across QA, Clinical Ops, CMC, and Research, with direct reporting to the SVP of Quality.

The position emphasizes vendor management, data integrity for BLA work, and ongoing training initiatives to ensure compliance with 21 CFR Part 11 and ICH guidelines.

Qualifications

• 10+ years in biotech/pharma QA with ownership of GxP systems.
• Proven audits, vendor management, and validations.
• Experience in clinical-stage or hybrid environments with QA operations.
• Strong understanding of ICH, FDA, and 21 CFR Part 11.

Responsibilities

• Lead GxP systems lifecycle across QA, Clinical Ops, CMC, and Research.
• Oversee vendor qualification, risk assessment, and ongoing oversight.
• Ensure data integrity for BLA-enabling work across functions.
• Deliver GxP training and drive continuous improvement initiatives.
• Manage documentation, batch records, stability studies, and QA releases.

Skills

QA Leadership

GxP Systems

Vendor Management

Audit Management

Regulatory Compliance

Education

Bachelor's degree in Life Sciences

Tools

eQMS

EDMS

Training systems

Clinical data systems

Job description

Candel Therapeutics, a biopharma company, seeks a seasoned Quality Systems leader in Needham, MA. The role focuses on GxP systems ownership across QA, Clinical Ops, CMC, and Research, with direct reporting to the SVP of Quality.

The position emphasizes vendor management, data integrity for BLA work, and ongoing training initiatives to ensure compliance with 21 CFR Part 11 and ICH guidelines.