Manager​/Sr Manager Quality Systems

Salary: $161k-$175k Hybrid
- Needham, MA office 3 days a week

Candel is a clinical-stage biopharmaceutical company developing innovative multimodal viral immunotherapies designed to harness the power of the immune system against cancer
. With positive Phase 3 results from our lead program and BLA readiness underway, Candel is reaching an important inflection point—one that creates the opportunity to translate scientific innovation into meaningful impact for patients, while the company continues to advance the next generation of programs across solid tumors.

This is an exciting time for Candel as we evolve from a focused clinical-stage biotechnology company toward an integrated biopharmaceutical organization.

Our people are at the heart of that journey! We believe breakthrough science is powered by people who challenge convention, bring different perspectives, collaborate across disciplines, and focus on shared outcomes. Candel’s culture is grounded in trust, flexibility, accountability, creativity, and a shared commitment to one goal:
improving the lives of patients and their families.

NOTE:

Title flexibility (Manager/flexible) will be considered based on experience and impact.

• Location: Hybrid (3 days/week in Needham, MA; 2 days remote)
• Type: Individual contributor (may have future direct reports)

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 Sr. Director of Quality and serve as a strategic partner across departments, while leading Candel’s Training and Documentation Control function, providing Quality Systems oversight of Deviations, CAPA, Change Control and other modules in ZenQMS and computer system validation.

This role will also support Quality Operations activities like executed batch record or deviation review. 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.

• Training Program Management and Continuous Improvement
  • Executing on and enhancing the strategic objectives related to the training program including continuous process improvement.
  • Generating and distributing periodic training-related metrics as well as expanded metrics and analysis in support of Quality Management Review.
  • Acting as subject matter expert for the training program and providing inspection support for training related requests.
• Document/Record Management and Continuous Improvement
  • Executing on and enhancing the strategic objectives related to the document and record management program including continuous process improvement.
  • Processing document creation and revision requests, editing documents and routing for review, approval, and archiving for all GxP document types including SOPs, batch records, protocols, reports, and approved external partner documents in ZenQMS.
  • Leading and executing strategic improvements related to document management workflow within ZenQMS.
  • Generating and distributing periodic document/record-releated metrics as well as expanded metrics and analysis in support of Quality Management Review.
  • Acting as subject matter expert for the document and records program and providing inspection support for document/record related requests.
• GxP Quality Systems Leadership
  • Leading periodic status meetings for…