Vice President, Quality Control
Candel Therapeutics
August 17, 2026
Remote friendly (Needham, MA)
United States
Operations
Position Summary
The Vice President, Quality Control will provide strategic, technical, and operational leadership for Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. Ensures QC strategy, laboratory operations, and data integrity systems align with regulatory requirements and product quality objectives.
Key Responsibilities
- Establish and lead the global QC strategy (infrastructure, testing frameworks, lifecycle management).
- Govern QC systems: specifications, test methods, environmental monitoring, stability, reference standards, and batch release support.
- Ensure QC compliance with global regulatory requirements (FDA, EMA, ICH), including cGMP and data integrity.
- Lead method qualification, validation, transfer, and performance monitoring (with Analytical Development).
- Oversee internal/external laboratory operations (CROs/CDMOs).
- Drive QC support for manufacturing (in-process, release, stability testing).
- Lead OOS/OOT investigations, deviations, and CAPA implementation.
- Support regulatory submissions and inspections (with QA/Regulatory Affairs).
- Advance QC via digital transformation/automation and lab systems (LIMS, ELN).
- Build and lead a high-performing QC organization.
- Manage budgets, capital planning, and resources.
Required Qualifications
- Advanced degree in a scientific discipline (preferred) or equivalent experience.
- 15+ years in biopharmaceutical Quality Control.
- Experience with biologics, viral vectors, or advanced therapies.
- Strong QC knowledge (validation, microbiology, stability, data integrity).
- Experience with global regulatory submissions/inspections.
- Proven leadership and team management.
Preferred Qualifications
- Experience building/transforming QC organizations.
- Advanced therapy modality experience (gene therapy, viral vectors).
- Digital QC systems experience.
- Managing external laboratory networks.
- Publications or regulatory engagement.
Application Instructions
Must be authorized to work in the US; no sponsorship. Not open to agency resume submissions at this time.
The Vice President, Quality Control will provide strategic, technical, and operational leadership for Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. Ensures QC strategy, laboratory operations, and data integrity systems align with regulatory requirements and product quality objectives.
Key Responsibilities
- Establish and lead the global QC strategy (infrastructure, testing frameworks, lifecycle management).
- Govern QC systems: specifications, test methods, environmental monitoring, stability, reference standards, and batch release support.
- Ensure QC compliance with global regulatory requirements (FDA, EMA, ICH), including cGMP and data integrity.
- Lead method qualification, validation, transfer, and performance monitoring (with Analytical Development).
- Oversee internal/external laboratory operations (CROs/CDMOs).
- Drive QC support for manufacturing (in-process, release, stability testing).
- Lead OOS/OOT investigations, deviations, and CAPA implementation.
- Support regulatory submissions and inspections (with QA/Regulatory Affairs).
- Advance QC via digital transformation/automation and lab systems (LIMS, ELN).
- Build and lead a high-performing QC organization.
- Manage budgets, capital planning, and resources.
Required Qualifications
- Advanced degree in a scientific discipline (preferred) or equivalent experience.
- 15+ years in biopharmaceutical Quality Control.
- Experience with biologics, viral vectors, or advanced therapies.
- Strong QC knowledge (validation, microbiology, stability, data integrity).
- Experience with global regulatory submissions/inspections.
- Proven leadership and team management.
Preferred Qualifications
- Experience building/transforming QC organizations.
- Advanced therapy modality experience (gene therapy, viral vectors).
- Digital QC systems experience.
- Managing external laboratory networks.
- Publications or regulatory engagement.
Application Instructions
Must be authorized to work in the US; no sponsorship. Not open to agency resume submissions at this time.