Sr Director, QA- GxP Systems

Candel Therapeutics; Needham (MA); Hybrid; USD 258,000 - 280,000; Full time

Job summary

Candel Therapeutics, a biopharma company, seeks a seasoned Quality Systems leader in Needham, MA. The role focuses on GxP systems ownership across QA, Clinical Ops, CMC, and Research, with direct reporting to the SVP of Quality.

The position emphasizes vendor management, data integrity for BLA work, and ongoing training initiatives to ensure compliance with 21 CFR Part 11 and ICH guidelines.

Qualifications

• 10+ years in biotech/pharma QA with ownership of GxP systems.
• Proven audits, vendor management, and validations.
• Experience in clinical-stage or hybrid environments with QA operations.
• Strong understanding of ICH, FDA, and 21 CFR Part 11.

Responsibilities

• Lead GxP systems lifecycle across QA, Clinical Ops, CMC, and Research.
• Oversee vendor qualification, risk assessment, and ongoing oversight.
• Ensure data integrity for BLA-enabling work across functions.
• Deliver GxP training and drive continuous improvement initiatives.
• Manage documentation, batch records, stability studies, and QA releases.

Skills

QA Leadership

GxP Systems

Vendor Management

Audit Management

Regulatory Compliance

Education

Bachelor's degree in Life Sciences

Tools

eQMS

EDMS

Training systems

Clinical data systems

Job description

• Location: Hybrid (3 days/week in Needham, MA; 2 days remote)
• Salary: 258,333 - $280,000 + 25% bonus

Why Work With Us?

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 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: Manage the lifecycle of GxP systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards.
• Vendor Oversight & Auditing: 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.
• Cross-functional Enablement: 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.
• Training & Continuous Improvement: Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the org.
• Documentation & Record Management: Oversee document bundling, review, and archiving for key deliverables like batch 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 experiencein biotech/pharma Quality Assurance, with direct ownership of GxP systems and a proven track record managing audits, vendors, and validations.
• Expertise witheQMS, EDMS, training systems, and other regulated platforms; familiarity with stability, batch records, and clinical supply workflows.
• Background inclinical-stage or hybrid clinical/commercial environments, with a handson approach to QA operations and system management.
• Strong understanding ofICH, FDA, and Part 11 requirements, and how they apply to cloud-based, outsourced, and evolving environments.
• Experience incross-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.

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.