Senior Quality Systems Lead – GxP, Training & Validation (Hybrid)

Candel Therapeutics, Inc.; Needham (MA); Hybrid; USD 161,000 - 175,000; Full time

Job summary

Candel Therapeutics, Inc. in Needham, MA is seeking a Manager/Sr Manager, Quality Systems to lead Training, Documentation Control, and QA systems oversight. This hybrid role reports to the Sr.

Director of Quality and focuses on Deviations, CAPA, Change Control, and CSV within ZenQMS while supporting QA operations and batch/document reviews. Ideal candidates have 10+ years in biotech/pharma QA, a Life Sciences degree, and a strong track record implementing compliant systems in clinical-stage or

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years of experience in biotech/pharma Quality Assurance with GxP ownership.
• Expertise with eQMS platforms, training systems, and regulated document types.
• Hands-on QA operations and system management in clinical-stage or hybrid settings.
• In-depth knowledge of ICH, FDA, and Part 11 for cloud-based and outsourced environments.
• Experience enabling cross-functional quality support for PD, IT, and Manufacturing.

Responsibilities

• Lead Training Program Management and drive continuous improvement.
• Oversee document and record management across SOPs, batch records, reports.
• Provide QA leadership for Deviations, CAPA, Change Control, and product records.
• Act as subject matter expert for ZenQMS and CSV governance.
• Provide inspection support and drive quality metrics for management reviews.
• Coordinate cross-functional enablement and quality operations support.

Skills

Quality Systems

GxP Compliance

Training Management

Document Control

CAPA/Deviations

Change Control

ZenQMS

CSV/Validation

Education

Bachelor's degree in Life Sciences

Tools

ZenQMS

EDMS

Training Systems

Job description

Candel Therapeutics, Inc. in Needham, MA is seeking a Manager/Sr Manager, Quality Systems to lead Training, Documentation Control, and QA systems oversight. This hybrid role reports to the Sr.

Director of Quality and focuses on Deviations, CAPA, Change Control, and CSV within ZenQMS while supporting QA operations and batch/document reviews. Ideal candidates have 10+ years in biotech/pharma QA, a Life Sciences degree, and a strong track record implementing compliant systems in clinical-stage or