Associate Director, Manufacturing Compliance

Role Summary

Associate Director, Manufacturing Compliance at Vericel Corporation. Oversees the organization, supervision, strategic initiatives, and technical support of manufacturing compliance and Quality Systems deliverables in the commercial manufacture of cell therapy products. Establishes process controls, KPIs and sustainable ways of working to drive performance improvements and reduce waste in Compliance Team deliverables. Provides project management for Manufacturing department objectives from process improvements to site and corporate goals. Supervises and provides technical expertise to the cell therapy manufacturing department.

Responsibilities

• Leads the Compliance Team in the Manufacturing organization in the delivery of GMP manufacturing investigations, root cause analysis, and corrective actions.
• Establishes, monitors, and analyzes Quality Systems deliverables from manufacturing activities to identify trends, risks, and opportunities for improvement.
• Drives GMP readiness and continuous improvement initiatives using industry best practices and risk-based approaches.
• Implements corrective and preventive actions (CAPA) to address quality issues and support operational excellence.
• Achieves annual goals for reduction in quality events, and time to completion of QMS records.
• Provides training and coaching on manufacturing compliance, quality and CI practices across all levels.
• Supervises the opening, investigation, and closure of all cell therapy manufacturing deviation reports, ensuring thorough investigations and appropriate corrective actions.
• Accounts 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.
• Provides leadership, guidance, and direction to Manufacturing staff consistent with cGMP quality governance.
• Coaches, develops and motivates Compliance Team staff in all aspects of their job performance and career development including training, feedback, rewards and performance management.
• Serves as manufacturing subject matter expert (SME) for cross functional teams.
• Interacts with project teams and cross-functional groups.
• Addresses and/or escalates 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.