Senior Director of Quality Assurance - GxP Systems

About Candel Therapeutics

Candel Therapeutics is a clinical-stage biopharma company devoted to developing off-the-shelf, multimodal immunotherapies aimed at eliciting personalized, systemic anti-tumor responses. Utilizing genetically modified adenovirus and HSV constructs, the company has achieved positive Phase 3 results for its lead candidate and is poised to bring transformative cancer therapies to patients. The organization fosters a culture centered around diversity, collaboration, and bold thinking within a supportive, mission-driven environment. Transparency, trust, and accountability are woven into the leadership approach and daily work culture.

Position Overview

This role offers a significant opportunity for an experienced quality systems professional who excels in dynamic and resourceful environments. Reporting directly to the Senior Vice President of Quality, the incumbent will act as a strategic partner across various departments while independently overseeing vendor management, computer system validation, and overall effectiveness of GxP systems. This position emphasizes ownership, innovation, and integrity in every task without micromanagement.

Key Responsibilities

• Lead the full lifecycle management of GxP systems across Quality Assurance, Clinical Operations, CMC, and Research to ensure full compliance with 21 CFR Part 11 and relevant industry standards.
• Manage vendor qualification, risk assessments, and ongoing audit oversight of internal and external providers, including eQMS, EDMS, training platforms, supply chain tools, and cloud-based clinical software.
• Take full ownership of computer system validation (CSV), incorporating SOP creation, vendor questionnaires, testing scripts and reports, periodic evaluations, revalidations, and maintaining constant inspection readiness.
• Enable cross-functional scientific teams such as Product Development, Analytical, and R&D by ensuring vendor integrity and data reliability supporting BLA-enabling activities, aligning clinical and commercial quality needs with effective systems management.
• Deliver GxP systems training and spearhead continuous improvement processes, including trend analysis and knowledge sharing throughout the organization.
• Supervise documentation management including bundling, reviewing, and archiving critical deliverables like batch records, stability studies, and QA release documents, ensuring audit readiness and efficient workflow.

Candidate Profile

• Bachelor’s degree in Life Sciences or a related technical domain.
• More than 10 years of hands-on experience in biotech or pharmaceutical Quality Assurance, with a track record of managing GxP systems, audits, vendors, and validation activities.
• Deep familiarity with electronic Quality Management Systems (eQMS), Electronic Document Management Systems (EDMS), training tools, and regulated software platforms; including knowledge of stability, batch record, and clinical supply procedures.
• Experience in clinical-stage or hybrid clinical and commercial industry settings with a proactive approach to QA system operations and management.
• Solid understanding of regulatory requirements such as ICH guidelines, FDA regulations, and 21 CFR Part 11, especially as they pertain to cloud-based and outsourced systems.
• Proven ability to support cross-functional quality initiatives involving teams from Product Development, Analytical science, and Clinical functions.
• Strong critical thinking and problem-solving skills capable of managing ambiguity, prioritizing workload, and maintaining progress independently.

Additional Information

• Work Location: Hybrid arrangement requiring three days weekly onsite in Needham, MA, and two days remote.
• Position Type: Individual contributor without direct reports.
• Compensation: Salary range of $258,333 to $280,000 with an additional 25% bonus potential.
• Authorization: Candidates must be authorized to work in the United States without sponsorship.
• Sponsorship is not offered for this position.