Director, Quality Control
Vericel Corporation, Burlington, MA, United States
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Director, Quality Control Regular Full-Time Professional Burlington, MA, US
4 days ago Requisition ID: 1289
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.
Responsibilities Quality Control Leadership & Compliance
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.
Strategic & Operational Leadership
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, elevate, 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.
Cross‑Functional Collaboration & Governance
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.
Qualifications
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.
Minimum 8+ 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 workflow in a multi‑tasking environment.
Working Conditions & Physical Demands
Ability to lift 40 pounds.
Weekend coverage (as needed or applicable).
Holiday coverage (as needed or applicable).
Why Vericel?
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.
The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $190,000 to $220,000 annually. The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.
EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
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Director, Quality Control Regular Full-Time Professional Burlington, MA, US
4 days ago Requisition ID: 1289
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.
Responsibilities Quality Control Leadership & Compliance
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.
Strategic & Operational Leadership
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, elevate, 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.
Cross‑Functional Collaboration & Governance
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.
Qualifications
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.
Minimum 8+ 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 workflow in a multi‑tasking environment.
Working Conditions & Physical Demands
Ability to lift 40 pounds.
Weekend coverage (as needed or applicable).
Holiday coverage (as needed or applicable).
Why Vericel?
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.
The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $190,000 to $220,000 annually. The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.
EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
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