Senior Director, Quality Control

Position Summary

The Senior Director of Quality Control is responsible for the strategy, leadership, and performance of Quality Control activities that support the safe, compliant and timely manufacture, testing and release of Vericel's cell therapy products to patients.

This role leads Quality Control laboratory operations and testing oversight, including product, raw material, microbiological, environmental monitoring, stability, and other testing performed internally or by external laboratories. The Senior Director establishes priorities, capacity plans, performance measures, and governance that support reliable testing and product disposition timelines while maintaining current Good Manufacturing Practice requirements and data integrity.

The Senior Director partners closely with Quality Assurance, Manufacturing, Supply Chain, Materials Management, Engineering, Validation, MSAT, Regulatory Affairs, and other functions to resolve quality issues, support regulatory commitments, and improve laboratory systems and processes. The role develops leaders and technical staff, ensures inspection readiness, and represents Quality Control during regulatory inspections and partner audits.

Schedule: This position is onsite, Monday through Friday, with three days at our Burlington, MA office and two days at our Cambridge, MA office.

Key Responsibilities

Quality Control Strategy and Laboratory Operations

• Set the Quality Control strategy and operating priorities in alignment with company, site, product, and Quality objectives.
• Provide oversight of laboratory operations and testing performed in support of raw materials, in-process samples, final product, stability programs, environmental monitoring, and other required quality activities.
• Ensure testing is planned, performed, reviewed, and reported accurately and within established timelines to support manufacturing and product disposition.
• Establish laboratory capacity and resource plans based on production schedules, testing demand, business priorities, and future growth.
• Maintain clear governance for work prioritization, issue escalation, and coordination across Quality Control teams and sites.

Compliance and Inspection Readiness

• Ensure Quality Control activities comply with applicable current Good Manufacturing Practice requirements, company procedures, regulatory commitments, and industry standards.
• Maintain inspection readiness across Quality Control laboratories, systems, records, and personnel.
• Represent Quality Control during regulatory inspections, customer or partner audits, and internal audits, and ensure timely, complete responses to requests and observations.
• Promote data integrity and complete, accurate, and contemporaneous documentation throughout laboratory operations.
• Review relevant regulatory submissions and post-approval changes for technical accuracy and consistency with Quality Control capabilities and commitments.

Testing Governance and Product Support

• Establish and maintain effective oversight of internal and external testing, including schedules, sample flow, results, exceptions, and release dependencies.
• Partner with Quality Assurance, Manufacturing and other functions to support timely product review, disposition and patient delivery while maintaining quality and compliance requirements.
• Ensure appropriate technical review and approval of laboratory methods, specifications, protocols, reports, and controlled procedures.
• Provide Quality Control leadership for new products, technology transfers, process changes, method transfers, validation activities, and laboratory readiness.
• Ensure qualified vendors and contract laboratories are appropriately governed and that performance, risks, and issues are routinely reviewed and escalated.

Investigations and Quality Systems

• Provide oversight of laboratory investigations, deviations, out-of-specification and out-of-trend results, corrective and preventive actions, change controls, and related risk assessments.
• Ensure investigations are scientifically sound, completed on time, and address root cause, product impact, recurrence risk, and effective corrective actions.
• Identify and escalate significant quality, compliance, testing, capacity, and supply risks with clear recommendations and recovery plans.
• Use investigation trends and performance data to identify recurring issues and strengthen laboratory controls and systems.

People and Financial Leadership

• Select, develop, and retain qualified leaders and staff with the technical knowledge and judgment required to perform Quality Control responsibilities.
• Set clear objectives, assign accountability, and provide ongoing coaching, feedback, recognition, and performance management.
• Ensure personnel are trained and qualified for assigned responsibilities and maintain an organization structure that supports effective oversight and succession planning.
• Develop and manage the Quality Control budget, headcount plan, operating expenses, capital needs, and external testing spend.
• Promote a culture of patient focus, quality, ethical conduct, collaboration, accountability, and timely escalation.

Performance Management and Continuous Improvement

• Establish and report performance measures for testing cycle time, schedule adherence, right-first-time performance, investigation timeliness, laboratory capacity, compliance, and external laboratory performance.
• Use performance data and tiered management routines to identify constraints, set priorities, and drive timely decisions and actions.
• Sponsor improvements to laboratory processes, systems, workflows, and electronic tools that increase reliability, efficiency, visibility, and compliance.
• Lead or support cross-functional initiatives that improve manufacturing support, testing readiness, product release, and organizational performance.

Qualifications

• Bachelor's degree in life sciences, chemistry, microbiology, engineering, or a related scientific or technical field; advanced degree preferred.
• Minimum 12 years of experience in pharmaceuticals, biologics, cell therapy, medical devices, or a related regulated industry.
• Minimum 8 years of progressive leadership experience, including demonstrated responsibility for managers and multi-level technical teams.
• Broad Quality Control experience supporting regulated manufacturing, laboratory operations, testing, investigations, and product disposition.
• Strong knowledge of current Good Manufacturing Practice requirements and applicable global regulatory expectations.
• Demonstrated ability to lead complex laboratory operations, manage competing priorities, and deliver reliable testing and release support.
• Experience establishing performance measures, capacity plans, budgets, and governance for a Quality Control organization.
• Strong scientific judgment and experience with laboratory investigations, data integrity, risk assessment, and corrective and preventive actions.
• Effective leadership, communication, collaboration, presentation, and influencing skills, including the ability to interact with senior management and regulatory authorities.
• Experience with cellular therapies, regenerative medicine, aseptic manufacturing, or biologics preferred.
• Experience with laboratory information management systems, electronic quality systems, and analytical or microbiological method transfer and validation preferred.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $230,000 - $250,000 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.