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.
Requirements
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 within 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.