Manager, Quality Engineering Product Surveillance

Repligen Corporation; Marlborough (MA); On-site; USD 111,000 - 156,000; Full time

Benefits offered by this job

Paid time off

Health benefits

Dental and Vision benefits

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corporation in Marlborough, MA, is seeking a Manager of Quality Engineering Product Surveillance to lead a team focused on quality investigations, CAPA, and continuous improvement within the ISO 9001 framework.

This hands-on leader partners with Engineering, Manufacturing, and Customer-facing teams to resolve product issues, drive cross-functional problem solving, coach staff, and strengthen customer confidence while achieving business results.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or 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 QMS principles.
• Demonstrated expertise in complaint handling, CAPA, root cause analysis, and CI methodologies.
• Experience with electronic quality management systems.
• Proven ability to lead teams, influence cross-functional partners, and drive results.
• Experience leading internal and external quality audits.

Responsibilities

• Lead and manage electronic complaint management system, ensuring data integrity and compliance.
• Provide day-to-day leadership for complaint handling, setting priorities and removing roadblocks.
• Lead cross-functional investigations with Quality, Manufacturing, Engineering, and Customer-facing teams to identify root causes.
• Champion corrective and preventive actions to reduce risk and prevent recurrence.
• Build partnerships with customers by communicating findings and updates on actions.
• Coach and develop team members in quality system requirements and ISO 9001 principles.
• Monitor, analyze, and report complaint metrics and KPIs for continuous improvement.
• Act as liaison between customers, Production, Engineering, and Quality teams to align outcomes.
• Balance customer needs with business objectives and quality requirements on escalations.
• Lead, develop, and retain a high-performing Quality team; deploy resources to meet demand.

Skills

Leadership

ISO 9001

CAPA

Root cause analysis

Quality management

Cross-functional collaboration

Quality investigations

Data-driven decisions

Communication

Education

Bachelor's degree in Engineering/Life Sciences

Tools

QMS

Salesforce

Job description

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.

Responsibilities

• 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.

Education & Experience

• 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 with business and manufacturing software applications, including word processing, presentations, spreadsheets, databases, and internet-based tools.
• Strong technical writing, communication, and presentation skills.
• Ability to effectively communicate with both internal and external stakeholders.
• Salesforce.com experience is a plus.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $110,858-$156,358. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.