GxP Systems Quality Leader – Hybrid (Senior Director)

Candel Therapeutics, Inc.; Needham (MA); Hybrid; USD 258,333 - 280,000; Full time

Job summary

Candel Therapeutics, Inc. in Needham is seeking a senior quality systems professional in a hybrid role with 3 days on-site and 2 days remote. You will own vendor oversight, CSV, and GxP system effectiveness, reporting to the SVP of Quality.

The role requires 10+ years in biotech/pharma QA, deep knowledge of GxP and Part 11, and cross-functional collaboration across QA, Clinical Ops, CMC and Research.

Qualifications

• 10+ years of biotech/pharma QA with direct ownership of GxP systems and audits/ validations.
• Experience with audits, vendor management and validations.
• Expertise with eQMS, EDMS, training systems and regulated platforms.
• Strong understanding of ICH, FDA and 21 CFR Part 11 requirements.

Responsibilities

• Oversee end-to-end lifecycle of GxP systems across QA, Clinical Ops, CMC, and Research.
• Ensure compliance with 21 CFR Part 11 and modern industry standards.
• Lead qualification, risk assessment, and ongoing oversight of vendors including eQMS, EDMS, training systems, etc.
• Own CSV activities: SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations.
• Bridge clinical and commercial quality expectations through practical systems thinking.
• Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management.
• Oversee document bundling, review, and archiving for batch records, stability studies, and QA releases.

Job description

Candel Therapeutics, Inc. in Needham is seeking a senior quality systems professional in a hybrid role with 3 days on-site and 2 days remote. You will own vendor oversight, CSV, and GxP system effectiveness, reporting to the SVP of Quality.

The role requires 10+ years in biotech/pharma QA, deep knowledge of GxP and Part 11, and cross-functional collaboration across QA, Clinical Ops, CMC and Research.