VP, Quality Control & Regulatory Readiness

Candel Therapeutics; Needham (MA); Hybrid; USD 290,000 - 335,000; Full time

Job summary

Candel Therapeutics in Needham, MA is seeking a Vice President, Quality Control to lead global QC strategy across development and commercial programs. You will oversee testing frameworks, Method validation, and lifecycle management for viral vectors and advanced therapies.

The role requires an advanced scientific degree and 15+ years in biopharma QC, with strong leadership, regulatory experience, and a track record of building high-performing QC teams. Hybrid work arrangement available.

Qualifications

• Advanced degree in a scientific discipline; 15+ years in Quality Control within biopharma.
• Experience with biologics, viral vectors, or advanced therapies.
• Experience with global regulatory submissions and inspections.
• Proven leadership and team management capabilities.

Responsibilities

• Lead global QC strategy across development and commercial programs.
• Oversee QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support.
• Ensure QC activities comply with FDA, EMA, ICH and data integrity standards.
• Lead method qualification, validation, transfer, and performance monitoring with Analytical Development.
• Manage internal and external laboratory operations, including CROs and CDMOs.
• Drive QC support for manufacturing operations including in-process, release, and stability testing.
• Provide leadership for OOS/OOT investigations, deviations, and CAPA implementation.
• Support regulatory submissions and inspections in collaboration with QA and Regulatory Affairs.
• Advance QC through digital transformation, automation, and laboratory systems (LIMS, ELN).
• Build and lead a high-performing QC organization and budget alignment.

Skills

QC leadership

Regulatory knowledge

Data integrity

Strategic leadership

Cross-functional collaboration

Communication

Education

Advanced degree in scientific discipline

Tools

LIMS

ELN

QA automation tools

Job description

Candel Therapeutics in Needham, MA is seeking a Vice President, Quality Control to lead global QC strategy across development and commercial programs. You will oversee testing frameworks, Method validation, and lifecycle management for viral vectors and advanced therapies.

The role requires an advanced scientific degree and 15+ years in biopharma QC, with strong leadership, regulatory experience, and a track record of building high-performing QC teams. Hybrid work arrangement available.