Lead, Quality Control

Vericel Corporation • Burlington, MA

9h • $100,000 - $108,000 • Onsite

About The Position

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary
This position is responsible for overseeing operations within the QC laboratory. This position is also responsible for hiring, training, supervising, developing and performance planning of staff and will provide day to day direction for direct reports. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QC laboratory while maintaining open communication channels to meet the needs of the organization.

Schedule: This position is onsite Sunday – Thursday
in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility.

Requirements

• Bachelor’s degree or equivalent and 6+ years of experience in a Quality Control lab setting or Master’s degree or equivalent and 4+ years of experience in a Quality Control lab setting
• Experience coordinating testing across Lot Release, QC Microbiology and Raw Material Testing.
• Experienced in microbial, molecular and/or cell-based assays.
• Experience troubleshooting and investigating assay and equipment issues.
• Experience with identifying root cause.

Nice To Haves

• Experience facilitating meetings.
• Familiarity with Deviation Management Systems (i.e.Trackwise).

Responsibilities

• Perform and oversee routine testing to support product disposition and lot release.
• Ensure all laboratory activities are conducted in compliance with cGMP requirements.
• Execute and/or coordinate lot release testing as required.
• Ensure completion of all scheduled daily testing; provide off-hours support as needed to meet testing timelines.
• Specify, procure, and oversee validation, calibration, and maintenance of laboratory equipment and instrumentation.
• Serve as a lead trainer for QC staff on laboratory assays and procedures.
• Act as lead investigator and/or approver for laboratory deviations, errors, and investigations (LIRs, OOS, OOT).
• Develop and implement effective CAPAs for laboratory investigations and deviations.
• Review and approve raw data for in-process and finished product testing to ensure cGMP compliance.
• Author, review, and maintain SOPs, including periodic reviews and process improvements.
• Provide leadership, direction, and daily oversight to QC staff in alignment with cGMP and company quality standards.
• Coach, mentor, and develop team members, including training, performance feedback, recognition, and disciplinary actions as needed.
• Ensure staff are appropriately trained and maintain proficiency in departmental processes and procedures.
• Foster a collaborative and high-performing team environment to support departmental objectives.
• Collaborate with QC functional areas to ensure timely support of lot release, facility, and raw material testing.
• Partner with Validation, Engineering, and Manufacturing to support project timelines without compromising quality.
• Represent QC in cross-functional meetings, as well as internal and external audits.
• Identify, address, and escalate compliance issues as appropriate.
• Perform other duties as assigned

Benefits

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees