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Senior Director, QC Laboratory
Job in
Needham, Norfolk County, Massachusetts, 02492, USA
Listed on 2026-07-04
Listing for:
Candel Therapeutics
Part Time
position Listed on 2026-07-04
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
This is a hybrid role in Needham, MA office (2-3 days a week)
Salary: $258,000-$285,000
Position SummaryThe Senior Director, QC Laboratory is responsible for the establishment, leadership, and ongoing operation of Candel Therapeutics’ internal GMP Quality Control laboratory.
The Senior Director, QC Laboratory 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, Manufacturing, and other internal stakeholders to support clinical development activities and future organizational growth.
Essential Areas of Responsibility- 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 future laboratory growth, supporting performance, development, and organizational 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, Regulatory Affairs, 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, succession planning, and long‑term QC capability development.
- Bachelor’s degree in a scientific discipline required; advanced degree preferred.
- Minimum of 10 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.
Must be authorized to work in US. We cannot provide sponsor ships.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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