Telecommut
- Location: Hybrid (3 days/week in Needham, MA; 2 days remote)
- Type: Individual contributor (no direct reports)
- Salary: 258,333 - $280,000 + 25% bonus
At 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. Learn more: www.candeltx.com
Position Summary:
This is a highly visible, unique opportunity for a seasoned quality systems professional who
thrives in fast-paced, resourceful environments. You’ll report directly to the SVP of Quality and
serve as a strategic partner across departments, while independently owning vendor oversight,
computer system validation, and overall GxP system effectiveness. You are a builder—of
systems, of processes, of trust.
We don’t believe in micromanagement here. We believe in hiring people who take ownership,
follow through, and bring integrity to every detail. If you're ready to roll up your sleeves, drive
change, and help bring a life-changing oncology therapy to market, read on.
This is not a role for the average. This is a role for someone ready to help launch a first-in-class
therapy, and do it the right way.
What You’ll Own
- Quality Operations Leadership:
Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards.
- Vendor Oversight & Auditing:
internal and external vendors—ranging from eQMS and EDMS to training systems,
supply chain tools, and cloud-based clinical applications.
- System Validation & Governance:
vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. Maintain
inspection-readiness at all times.
- Cross-functional Enablement:
BLA-enabling work. Bridge clinical and commercial quality expectations through
practical systems thinking.
- Training & Continuous Improvement:
analysis, and knowledge management across the org.
- Documentation & Record Management:
records, stability studies, and QA releases. Ensure audit-ready files and streamlined
workflows
What You Bring
- Bachelor's degree in Life Sciences or a related technical field.
- 10+ years of experience in biotech/pharma Quality Assurance, with direct ownership of
- Expertise with eQMS, EDMS, training systems, and other regulated platforms; familiarity
- Background in clinical-stage or hybrid clinical/commercial environments, with a handson approach to QA operations and system management.
- Strong understanding of ICH, FDA, and Part 11 requirements, and how they apply to
- Experience in cross-functional quality enablement, supporting teams like PD, Analytical,
- Critical thinker with the ability to navigate ambiguity, prioritize work, and maintain
NOTE: All applicants must be authorized to work in the US and do not require sponsorship.
Unfortunately, we are unable to provide sponsorship of any kind at this time
