Senior Director, Quality

Responsibilities

• Lead and execute the quality strategy across Repligen’s Chromatography network, with accountability for Quality Assurance, Quality Systems, Quality Compliance, Validation, Quality Control, Supplier Quality partnership, and Customer Quality activities.
• Ensure compliance with company policies, quality standards, ISO requirements, applicable regulations, and customer expectations across all network sites.
• Provide strategic leadership and oversight for customer audits, certification audits, and interactions with regulatory agencies.
• Drive the development, implementation, harmonization, and continuous improvement of quality systems, processes, and procedures to ensure product quality, reliability, and compliance.
• Partner with Commercial, Product Management, Operations, and Global Supplier Quality to ensure effective management of customer quality agreements, complaints, customer satisfaction, change notifications & supplier performance.
• Establish and monitor key quality metrics, using data-driven insights and customer feedback to drive operational excellence and continuous improvement.
• Collaborate with senior leadership to foster a culture of quality, accountability, risk management, and proactive issue resolution across the network.
• Lead investigations, compliance initiatives, and quality improvement programs to address complex quality challenges and support business growth.
• Build, develop, and mentor a high-performing quality organization, including workforce planning, succession planning, employee development, resource management & counselling.
• Represent Quality on cross-functional projects, strategic initiatives, and leadership forums, serving as a key member of the Global Quality Leadership Team.
• Participate in project teams and/or working groups, as required.

• Bachelor’s degree in science, Engineering, Quality, Life Sciences, or a related field; advanced degree preferred.
• 15+ years of quality leadership experience within the bioprocessing, biotechnology, pharmaceutical, medical device, or other regulated manufacturing industries.
• 5+ years of leadership responsibility for a quality organization, including accountability for Quality Assurance, Quality Systems, Compliance, and Quality Control functions.
• 7+ years of people leadership experience with a demonstrated ability to build, develop, and engage high-performing teams.
• Experience developing and executing quality strategies across multiple sites, functions, or global operations.
• Strong experience leading customer audits, certification audits, and interactions with regulatory authorities.
• Thorough knowledge of ISO 9001 requirements
• Experience with ISO 13485 quality management systems and sterilization and/or sterility assurance programs is highly desirable.
• GMP knowledge is highly desirable.
• Experience with in chromatography, bioprocessing, or related life sciences technologies is preferred.
• Excellent leadership, communication, stakeholder management, analytical, and problem-solving skills, with the ability to influence at all levels of the organization.

• Quality Compliance
• Validation
• Quality Control
• Quality Improvement Programs
• Data-Driven Insights
• Quality Metrics Monitoring
• Regulatory Agency Interaction
• Quality Strategy Execution
• Sterilization Assurance Programs
• Bioprocessing Technologies

• Leadership
• Communication
• Stakeholder Management
• Analytical Skills
• Problem-Solving