Manager, Quality Engineering Product Surveillance

The Manager, Quality Engineering Product Surveillance is a key leadership role responsible for advancing product quality, strengthening customer confidence, and supporting Repligen's ISO 9001 Quality Management System. Reporting to the QA Director, this individual will lead a team focused on quality investigations, continuous improvement, and cross-functional problem solving while fostering a culture of accountability, collaboration, and operational excellence. This hands‑on leader will partner closely with Engineering, Manufacturing, Quality, and Customer-facing teams to address complex quality challenges, drive sustainable improvements, and ensure timely resolution of product‑related issues.

The ideal candidate brings strong quality systems expertise, a passion for developing people, and the ability to influence across functions while maintaining a strong focus on customer success, team development, and business results. This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results in all aspects of work.

• Lead and support the ongoing management and maintenance of the electronic complaint management system, ensuring data integrity, efficiency, and compliance with established processes.
• Provide day‑to‑day leadership for complaint handling activities, establishing priorities, managing escalations, removing roadblocks, and ensuring timely, high‑quality execution across the team.
• Lead complex, cross‑functional investigations involving Quality, Manufacturing, Engineering, and Customer‑facing teams to identify root causes and drive effective resolution of product and service failures.
• Champion a proactive approach to problem‑solving by driving corrective and preventive actions that address root causes, reduce risk, and prevent recurrence.
• Build strong partnerships with customers by participating in investigation discussions, communicating findings, and providing clear, timely updates on corrective actions and quality improvements.
• Develop, coach, and empower team members to confidently execute complaint handling activities while strengthening their understanding of quality system requirements, customer expectations, and ISO 9001 principles.
• Drive accountability through the monitoring, analysis, and communication of complaint metrics and key performance indicators, leveraging trend data to identify opportunities for continuous improvement.
• Serve as a trusted liaison between customers, Production, Engineering, and Quality teams, fostering collaboration and alignment to achieve the best possible outcomes for both customers and the business.
• Support strategic customer priorities and escalations by balancing customer needs, business objectives, and quality requirements with sound judgment and a sense of urgency.
• Lead, develop, and retain a high‑performing Quality team through coaching, feedback, talent development, and performance management.
• Plan and deploy quality resources effectively to meet business demands while maintaining high standards for customer responsiveness, compliance, and operational excellence.
• Demonstrate courage and leadership in addressing complex quality issues, making data‑driven decisions, and driving improvements that strengthen both customer confidence and product quality.

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 7+ years of Quality Assurance and Quality Management Systems experience.
• Minimum of 3 years of leadership experience.
• Strong knowledge of ISO 9001 requirements and quality management system principles.
• Demonstrated expertise in complaint handling, CAPA, root cause analysis, and continuous improvement methodologies.
• Experience working with electronic quality management systems.
• Proven ability to lead teams, influence cross‑functional partners, and drive results with minimal supervision.
• Experience leading internal and external quality audits.
• Strong collaboration and stakeholder management skills across multiple functions and organizational levels.
• Excellent organizational skills and attention to detail.
• Proficiency…