Director, Quality Control

Vericel Corporation•Burlington, MA

1d•$190,000 - $220,000•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: The Director of Quality Control (QC), Biological & Raw Material Testing, leads and oversees all QC testing operations, including in-process, final product, raw material, and stability testing, as well as raw material inspection and release, in compliance with approved methods and Standard Operating Procedures. This role is accountable for ensuring the accuracy, integrity, and compliance of QC activities, including method validations and transfers, protocol and procedure review, and issuance of Certificates of Analysis. The Director also ensures delivery of critical QC programs and data, including reference standards and critical reagents management, Annual Product Reviews, and Quality Management Review (QMR) contributions, while maintaining alignment with regulatory and quality system requirements. Schedule: This position is onsite Monday-Friday primarily in our Burlington office with occasional days in our Cambridge office.

Requirements

Bachelor’s degree or equivalent in Chemistry, Microbiology or Biological Sciences and 10+ years of experience in a cGMP pharmaceuticals or biotech industry or Master’s degree or equivalent in Chemistry, Microbiology, or Biological Sciences and 8+ years of experience in a cGMP pharmaceutical or biotech industry.
Minimum8+ years of cGMP laboratory management experience.
Experienced in molecular and cell-based assays (mycoplasma, endotoxin, sterility, ID, potency, or equivalent).
Demonstrate knowledge of USP, EP, JP monographs
Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
Working knowledge of quality systems and domestic and international regulatory requirements.
Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as raw materials, cell banks, in-process, and drug product.
Experience in managing other managers.
Familiarity with cGMP systems (e.g. TrackWise, Veeva, LIMS, etc.).
Ability to work independently, or under minimal supervision, and with flexibility to handle work flow in a multi-tasking environment.

Responsibilities

Lead and oversee the development, implementation, and continuous improvement of Quality Control (Biological Testing & Raw Materials) systems.
Ensure execution and compliance of all QC testing (raw materials, in-process, final product, stability) in accordance with cGMP, SOPs, and validated methods.
Direct QC laboratory operations to maintain GxP compliance, including equipment qualification, calibration, maintenance, and sample management.
Own and drive Quality System processes (OOS/OOT, deviations, CAPAs, change controls), ensuring timely, thorough, and compliant resolution.
Champion data integrity and ensure consistent application across QC operations.
Establish, monitor, and report QC metrics to drive performance, inspection readiness, and continuous improvement.
Lead method transfers in collaboration with R&D and external laboratories.
Ensure inspection readiness and lead regulatory audit preparation and response activities.
Set direction and drive execution of QC strategy aligned with organizational goals and regulatory expectations.
Drive innovation and continuous improvement, including adoption of new technologies and best practices.
Ensure delivery of QC objectives, holding teams accountable for timelines, quality, and compliance outcomes.
Represent QC in cross-functional initiatives and influence decision-making at the organizational level.
Identify, escalate, and resolve compliance and operational risks.
Build, lead, and develop a high-performing QC team through hiring, coaching, and succession planning.
Direct and empower staff to execute effectively within safety, quality, regulatory, and budget expectations.
Provide budget input and manage resources to support operational and capital needs.
Foster a culture of quality, accountability, and continuous development.
Collaborate and influence cross-functional teams (R&D, Manufacturing, Quality, external partners) to ensure alignment of QC systems.
Lead and facilitate meetings, workshops, and governance forums.
Communicate performance, trends, and risks to senior leadership and stakeholders.
Author, review, and approve SOPs and ensure alignment with regulatory and industry standards.