Senior Quality Assurance Document Specialist

Join Candel: Advancing Cancer ImmunotherapiesAt Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it's an exciting time to join us and help bring transformative cancer treatments to patients.Position Summary: Cross-functional to support relevant Quality Systems GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH Q10, ISO). Also supports the implementation and improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.Administers Document Management Program and provides support to end users for the creation, revision, and retirement of documents including:Reviews GxP documents and records for completeness and compliance with internal procedures and applicable regulations and ensures ALCOA++ principles are followed to ensure data robustness.Supports and manages document lifecycle in the Electronic Quality Management System (eQMS)Maintains and improves Document Management Program proceduresProvides training on the Document Management ProgramActs as Administrator for Document Management within the eQMSManages physical document archival and retention programAdministers the Training Management Program and provides support to end users for the maintenance of training activities including:Maintains user roles, training curricula, and training assignments.Maintains and improves Training Management Program proceduresProvides training on the Training Management Program, as well as Employee Onboarding Program related policies and procedures.Assists document owners in generating training materials and quiz questionsActs as Administrator for Training Management within the eQMSAdditional duties to include:Inspection readiness and execution tasks, as assignedInternal audit supportDeviation, CAPA, Change Control, and Supplier Qualification supportPreparation of Quality Management System metricseQMS, design and validation supportContinuous Improvement initiativesOther responsibilities as assigned by managementEducation, Experience and Skill Requirements: Education:BS/BA in a scientific or engineering discipline with 6+ years of experience in pharmaceutical/ biotech industry within Quality Assurance or Quality (Assurance) exposure, or equivalent experiencesOr, Associate's degree in a scientific or engineering discipline with 8+ years of Quality experience or Quality (Assurance) exposure or equivalent experiencesExperience:Knowledge in 21 CFR Part 11, Annex 11, CFR 210, CFR 211, GxP practicesKnowledge of current regulatory and industry guidelinesExposure to global health agency regulationsInternal audit/self-inspection experienceExperience in electronic Quality Management SystemsProficient in Microsoft Office suite (Word, Excel, PowerPoint, Outlook, and Teams)Familiar with SmartSheet and SharePoint platformsExcellent written and oral communication skillsStrong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail in a rapidly changing environmentAbility to proactively resolve issues in a diplomatic, flexible, and constructive mannerHighly motivated, ethical individual with excellent time management skillsSkilled at building consensus, securing stakeholder buy-in, and advancing strategic priorities in a matrixed organizationMust be authorized to work in US. We cannot provide sponsorships. *** NOTE: We are not accepting resumes from agencies. ***