QC Documentation Specialist

About the Company

Candel Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative off-the-shelf multimodal immunotherapies that create personalized systemic anti-tumor responses. Their platforms employ genetically modified adenovirus and HSV constructs, and with positive Phase 3 trial results for their leading candidate, they are at an exciting phase of bringing transformative cancer treatments to patients.

Why Join Us?

At Candel, our people are the core of our success. We foster a culture valuing diversity, teamwork, and bold ideas within a mission-driven and supportive environment. Leadership is transparent and empowering, emphasizing trust, flexibility, accountability, and encouraging ownership and innovation daily.

Role Overview

This role is cross-functional, focusing on supporting Quality Systems GxP activities adhering to regulations such as FDA and EU, along with standards like ICH Q10 and ISO. The specialist will contribute to implementing and enhancing Quality Systems to maintain cGMP compliance and ensure inspection readiness.

Key Responsibilities

• Administer the Document Management Program and assist users with document creation, updates, and retirement.
• Review GxP-related documents and records to ensure completeness, regulatory compliance, and adherence to ALCOA++ data integrity principles.
• Manage document lifecycle within the Electronic Quality Management System (eQMS) and improve related procedures.
• Provide training on Document Management Program usage.
• Serve as Document Management Administrator within the eQMS.
• Oversee physical document archiving and retention processes.
• Administer the Training Management Program, maintaining training activities, curricula, user roles, and assignments.
• Enhance Training Management procedures and deliver training, including onboarding-related policies.
• Assist document owners in creating training materials and quizzes.
• Act as Training Management Administrator within the eQMS.
• Support inspection readiness and execution.
• Assist with internal audits and self-inspections.
• Provide support for deviations, CAPA, change control, and supplier qualification processes.
• Prepare Quality Management System metrics.
• Contribute to eQMS design and validation efforts.
• Participate in continuous improvement initiatives.
• Perform other management-assigned tasks as needed.

Required Qualifications & Experience

• Bachelor’s degree in scientific or engineering discipline with over 6 years of experience in pharmaceutical/biotech quality assurance or equivalent; or an Associate’s degree with 8+ years of relevant experience.
• Strong knowledge of 21 CFR Part 11, Annex 11, CFR 210, CFR 211, and GxP regulations.
• Familiarity with current regulatory frameworks, including global health agency regulations.
• Experience in internal auditing and self-inspection processes.
• Proficiency with Electronic Quality Management Systems.
• Skilled in Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Teams) and familiarity with SmartSheet and SharePoint.
• Excellent verbal and written communication abilities.
• Exceptional organizational skills to effectively manage multiple priorities with attention to detail in a dynamic environment.
• Ability to resolve issues proactively and diplomatically.
• Highly motivated and ethical with strong time management capabilities.
• Adept at building consensus, securing buy-in, and advancing strategic goals within matrixed organizational structures.
• Authorization to work in the U.S. without sponsorship.

Additional Information

• Location: Onsite at Needham, MA
• Salary range: $88,000 to $100,000 annually
• Note: The company is not accepting resumes from recruitment agencies.