Senior Manager, Quality Control Operations

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: Responsible for Quality Control operations including responsibility for the overall trending of QC test data, oversight of QC investigations, CAPAs, Change Controls, EM trending and investigations, LIMS implementation, oversight of CTLs, sample management, backups, and retains. Responsible for overseeing the inventory of laboratory chemicals and critical reagent supplies, and management of stability testing across both Cambridge and Burlington facilities

Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work five days per week on-site.

Location: This role will generally be working out of our Cambridge, MA office with an eventual move to our state-of-the-art facility located in Burlington, MA.

DUTIES AND RESPONSIBILITIES

• Develop and implement sample receipt and retain management procedures.
• Implement and manage critical reagent/control procedures.
• Perform routine trending of all QC test methods and EM on a monthly and quarterly basis.
• Oversight of QC investigations, CAPAs, Change Controls, and EM investigations.
• Manage the stability program (including study implementation, pull schedule and trending)
• Collaborates with 3rd party/ external contract testing labs to onboard materials, methods, and on external quality investigations as applicable.
• Provides technical and operational expertise for training and developing staff, assisting in troubleshooting, and performing investigations for out of specification results.
• Act as the QC lead on the implementation of LIMS.
• Collaborate with Engineering and Facilities on the preventative maintenance and calibration of QC equipment.
• Ensure that all Quality Control activities are conducted in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements. Practice safe work habits and adheres to Vericel's safety procedures and guidelines.
• Author revisions to SOPs for managerial review and approval and drafts new documentation where appropriate.
• Author and review IND/NDA Module 3 sections, as needed.
• Maintain collaborative relationships with outsourced testing partners, actively managing all contracted activities.
• Other duties as assigned.

Staff Responsibilities:

• Coach direct reports to evaluate and execute continuous improvement, develop their skill sets, and create an environment of continuous learning, improvement, and innovation.
• Maintain and communicate team performance metrics, setting high expectations for team performance.
• Drives staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns.

Basic Qualifications:

• Bachelor's degree in microbiology, molecular biology, biochemistry or a related discipline with 8+ years' industry experience or MS with 6+ years' industry experience in cGMP lab environment, or equivalent.
• Strong knowledge of cGMPs and Quality Systems.

Preferred Qualifications:

• Minimum of 8+ years in cell culture, microbial and/or molecular assays
• Knowledge of cGMP/ICH/FDA/EU regulations
• Strong initiative and scientific leadership; work with limited direction in a fast-paced environment
• Collaborative team player who fosters open communication and builds relationships with stakeholders
• Strong analytical, organization, and communication skills with a positive attitude
• Strong project management skills.
• Strong knowledge of statistical software and principles.
• Strong background on data integrity.
• Knowledge of Laboratory Information Management Systems (LIMS).
• Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
• Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs).

WORKING CONDITIONS AND PHYSICAL DEMAND

• Ability to lift 40 lbs.

• Flexibility with scheduling requirements-may include shifts, overtime, weekends, and holiday coverage, including during adverse weather conditions.
• May carry company issued cell phone for off-shift remote alarm coverage.
• Required to gown into classified manufacturing ISO 7 clean room areas.
• Ability to lift 40 lbs.

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.

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.