Associate Director, Manufacturing Compliance

Job Description

Job Description

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 Associate Director, Manufacturing compliance will oversee the organization, supervision, strategic initiatives, and technical support of manufacturing compliance and Quality Systems deliverables in the commercial manufacture of cell therapy products. The AD will establish process controls, KPIs and sustainable ways of working to drive performance improvements and reduce waste in Compliance Team deliverables. Deliver project management of Manufacturing department objectives ranging from process improvements to site and corporate goals. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the cell therapy manufacturing department.

Schedule: This position is in-office Monday-Friday.

Position Scope:

• Leads the Compliance Team in the Manufacturing organization in the delivery of GMP manufacturing investigations, root cause analysis, and corrective actions.
• Establish, monitor, and analyze Quality Systems deliverables from manufacturing activities to identify trends, risks, and opportunities for improvement.
• Drive GMP readiness and continuous improvement initiatives using industry best practices and risk-based approaches.
• Implement corrective and preventive actions (CAPA) to address quality issues and support operational excellence.
• Achieve annual goals for reduction in quality events, and time to completion of QMS records.
• Provide training and coaching on manufacturing compliance, quality and CI practices across all levels
• Supervise the opening, investigation, and closure of all cell therapy manufacturing deviation reports, ensuring a proper thorough investigation, and appropriate corrective actions.
• Accountable for project completions and achievement of compliance goals relative to deviations, change controls, CAPA and Effectiveness reviews.
• Owns, drives, and leads implementation of manufacturing change controls to ensure effective change management and compliance with regulatory and operational standards.
• Provide leadership, guidance, and direction to Manufacturing staff consistent with cGMP quality governance.
• Coach, develop and motivate Compliance Team staff in all aspect of their job performance and career development including training, feedback, rewards and performance management.
• Serve as manufacturing subject matter expert (SME) for cross functional teams.
• Interact with project teams and cross-functional groups.
• Address and/or escalate site compliance problems and issues.

Qualifications:

• Bachelor’s degree in Life Sciences or equivalent and 8+ years of working in a GMP environment.
• In-depth knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
• Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics.
• Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies. Strong Lean Six Sigma experience.
• Previous supervisory experience.
• Must possess solid working knowledge of MS Office.

Preferred Qualifications:

• Subject matter experience in cell therapy manufacturing processes.
• Excellent communication and change management abilities.
• Proficient in managing complex projects, achieving goals and deadlines.

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 $133,000 to $193,000 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.