Senior Director, Quality Control - Cell Therapy Innovation

Vericel Corporation; Burlington (MA); Presencial; USD 230.000 - 250.000; Jornada completa

Descripción de la vacante

Vericel Corporation in Burlington, MA seeks a Senior Director of Quality Control to lead strategy, leadership, and performance of QC activities that support safe, compliant manufacturing, testing, and release of cell-therapy products.

The role collaborates across Quality Control, Quality Assurance, Manufacturing, and regulatory affairs, guiding lab operations at Burlington and Cambridge sites, ensuring data integrity, timely testing, and inspection readiness.

Formación

• Bachelor's degree in life sciences or engineering.
• Minimum 12 years in pharmaceuticals, biologics, cell therapy, medical devices, or related regulated industry.
• Minimum 8 years of progressive leadership experience overseeing multi-level technical teams.
• Strong knowledge of current Good Manufacturing Practice requirements and global regulatory expectations.
• Experience with laboratory investigations, data integrity, and corrective and preventive actions.

Responsabilidades

• Set Quality Control strategy and operating priorities aligned with company objectives.
• Oversee laboratory operations supporting raw materials, in-process samples, final product, stability programs, and environmental monitoring.
• Ensure testing is planned, performed, reviewed, and reported on time to support manufacturing and product disposition.
• Represent Quality Control during regulatory inspections, audits, and responses with accuracy and timeliness.
• Provide leadership for new products, technology transfers, method transfers, validation activities, and lab readiness.

Conocimientos

Leadership

Regulatory knowledge

Quality control

Data integrity

Educación

Bachelor's degree

Advanced degree preferred

Herramientas

LIMS

Electronic quality systems

Descripción del empleo

Vericel Corporation in Burlington, MA seeks a Senior Director of Quality Control to lead strategy, leadership, and performance of QC activities that support safe, compliant manufacturing, testing, and release of cell-therapy products.

The role collaborates across Quality Control, Quality Assurance, Manufacturing, and regulatory affairs, guiding lab operations at Burlington and Cambridge sites, ensuring data integrity, timely testing, and inspection readiness.