Senior Director of Quality Control, Cell Therapy

Vericel® Corporation; Burlington (MA); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Mission-Driven Work

Innovative Products

Career Growth

Collaborative Culture

Job summary

Vericel Corporation in Massachusetts seeks a Senior Director of Quality Control to lead strategy, governance, and performance of QC activities ensuring safe, compliant manufacture and release of cell therapy products. You will manage lab operations, testing oversight, and collaborations across QA, Manufacturing, Supply Chain, and Regulatory Affairs to address issues and support regulatory commitments.

The role emphasizes data integrity, inspection readiness, and leadership development of

Qualifications

• Bachelor's degree in life sciences, chemistry, microbiology, engineering, or related field; advanced degree preferred.
• Minimum 12 years in pharmaceuticals, biologics, cell therapy, medical devices, or related regulated industry.
• Minimum 8 years of progressive leadership experience.
• Broad Quality Control experience supporting regulated manufacturing, laboratory operations, testing, investigations, and product disposition.
• Strong knowledge of Good Manufacturing Practice requirements and global regulatory expectations.
• Experience leading complex laboratory operations and managing priorities.
• Experience with performance measures, capacity plans, and governance for QC.
• Strong scientific judgment, data integrity, risk assessment, and CAPA experience.
• Leadership, communication, collaboration, and influencing skills with senior management and regulators.
• Experience with cellular therapies, regenerative medicine, aseptic manufacturing, or biologics preferred.
• Experience with LIMS and electronic quality systems; analytical/microbiological method transfer and validation preferred.

Responsibilities

• Lead QC strategy and laboratory operations for materials, in-process, final product, stability, and environmental monitoring testing.
• Ensure testing is planned, performed, reviewed, and reported on time to support manufacturing and product disposition.
• Establish laboratory capacity and resource plans aligned with production schedules and growth.
• Maintain governance for prioritization, escalation, and cross-site coordination.
• Represent QC during regulatory inspections, audits, and provide timely responses.

Skills

Quality Control Leadership

Laboratory Operations

Regulatory Compliance

Data Integrity

CAPA & Investigations

Budget & People Leadership

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

LIMS

Electronic Quality Systems

Analytical method transfer & validation

Job description

Vericel Corporation in Massachusetts seeks a Senior Director of Quality Control to lead strategy, governance, and performance of QC activities ensuring safe, compliant manufacture and release of cell therapy products. You will manage lab operations, testing oversight, and collaborations across QA, Manufacturing, Supply Chain, and Regulatory Affairs to address issues and support regulatory commitments.

The role emphasizes data integrity, inspection readiness, and leadership development of