QC Lab Director

Candel Therapeutics•Needham, MA

2d•Hybrid

About The Position

The QC Lab Director is responsible for the establishment, leadership, and ongoing operation of Candel Therapeutics’ internal GMP Quality Control laboratory. The QC Lab Director will provide leadership, direction, and technical oversight to the QC team while ensuring compliance with GMP requirements and internal quality standards. This role partners closely with Quality Assurance, Analytical Development, R&D, and other internal stakeholders to support clinical development activities. This is a hybrid role in Needham, MA office This is a salaried, contract role until the end of 2026

Requirements

Bachelor’s degree in a scientific discipline required; advanced degree preferred.
Minimum of 8 years of experience in a GMP Quality Control laboratory environment within biotech or pharmaceutical organizations.
Demonstrated experience operating within a true QC organization, with a strong understanding of QC structure, controls, and GMP rigor.
Prior experience leading, mentoring, or managing QC laboratory staff.
Experience supporting GMP inspections, audits, and quality system activities impacting QC operations.
Strong interpersonal, leadership, and communication skills with the ability to partner effectively across functions.
Comfort working in a build-phase or evolving environment where systems and infrastructure are developing.
Proficiency with standard office software including Microsoft Word, Excel, and PowerPoint.

Responsibilities

Provide leadership and oversight for the internal GMP QC laboratory, including establishment of laboratory operations, workflows, and execution standards.
Lead, mentor, and develop QC laboratory staff, fostering a collaborative, accountable, and compliant team culture.
Directly manage internal QC staff and planned contract resources, supporting performance, growth, and role readiness.
Ensure QC laboratory operations are conducted in compliance with GMP requirements, internal SOPs, and data integrity expectations.
Serve as a key QC partner to Quality Assurance for deviations, investigations, change controls, CAPAs, and inspection readiness activities.
Provide hands-on leadership and operational support in the laboratory environment as needed to meet business and quality objectives.
Collaborate cross-functionally with Analytical Development, R&D, Manufacturing, and other internal stakeholders to support testing needs and program timelines.
Support audit and inspection activities related to QC laboratory operations, documentation, and systems.
Implement and maintain practical, scalable QC processes appropriate for a growing biotech organization.
Drive continuous improvement initiatives within the QC laboratory while maintaining appropriate controls and compliance.
Contribute to staffing plans, onboarding, training, and long-term QC capability development.