Candel Therapeutics · 1 week ago
Director / Sr Director Quality Assurance (GxP)
Needham, MA
Full-time
Hybrid
Director/Executive
$242K/yr - $270K/yr
10+ years expCandel Therapeutics is a clinical-stage biopharma company focused on developing innovative cancer immunotherapies. The role involves managing GxP systems, vendor oversight, and ensuring compliance while driving continuous improvement initiatives in a fast-paced environment.
BiotechnologyGeneticsHealth CareHealth DiagnosticsMedicalTherapeutics
No H1B
Responsibilities
Manage the end-to-end lifecycle of GxP systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards
Lead qualification, risk assessment, and ongoing oversight of a diverse ecosystem of internal and external vendors—ranging from eQMS and EDMS to training systems, supply chain tools, and cloud-based clinical applications
Own all CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. Maintain inspection-readiness at all times
Support scientific teams (PD, analytical, R&D) by ensuring vendor and data integrity for BLA-enabling work. Bridge clinical and commercial quality expectations through practical systems thinking
Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the org
Oversee document bundling, review, and archiving for key deliverables like batch records, stability studies, and QA releases. Ensure audit-ready files and streamlined workflows
Qualification
Required
Bachelor's degree in Life Sciences or a related technical field
10+ years of experience in biotech/pharma Quality Assurance, with direct ownership of GxP systems and a proven track record managing audits, vendors, and validations
Expertise with eQMS, EDMS, training systems, and other regulated platforms; familiarity with stability, batch records, and clinical supply workflows
Background in clinical-stage or hybrid clinical/commercial environments, with a hands-on approach to QA operations and system management
Strong understanding of ICH, FDA, and Part 11 requirements, and how they apply to cloud-based, outsourced, and evolving environments
Experience in cross-functional quality enablement, supporting teams like PD, Analytical, and Clinical in system compliance
Critical thinker with the ability to navigate ambiguity, prioritize work, and maintain momentum without daily direction
All applicants must be authorized to work in the US and do not require sponsorship
Company
Candel Therapeutics
Candel Therapeutics develops cancer immunotherapies designed to improve the lives of cancer patients and their families.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$321.9MKey Investors
Trinity CapitalSilicon Valley BankNorthpond Ventures
2025-10-14Post Ipo Debt· $50M
2025-06-24Post Ipo Equity· $15M
2024-12-12Post Ipo Equity· $92M
Leadership Team
Nathan Caffo
Chief Business Officer
Recent News
24-7 Press Release Newswire
2025-11-27
Candel Therapeutics, Inc
2025-11-14
2025-11-14
Company data provided by crunchbase