Senior Director, Quality

Repligen Corporation; Waltham (MA); Hybrid; USD 191,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Job summary

Repligen seeks a Senior Director, Quality to lead global QA across Filtration & System networks, ensuring regulatory compliance, robust quality systems, and customer satisfaction. You will drive strategic quality initiatives, partner with Operations, Regulatory, and Commercial, and build a high-performing team across locations.

You will oversee audits, supplier quality, change management, and continuous improvement programs within ISO 9001/13485 environments, guiding quality excellence worldwide.

Qualifications

• 15+ years of quality leadership experience in regulated manufacturing industries
• 5+ years leading a quality organization (QA, QC, Compliance, and Systems)
• 7+ years of people leadership and team development
• Experience leading customer and certification audits with regulatory authorities
• Thorough knowledge of ISO 9001; ISO 13485 and GMP knowledge desirable

Responsibilities

• Lead quality strategy across global networks, with QA, Systems, Compliance, Validation, and Customer Quality activities
• Ensure compliance with policies, ISO requirements, regulations, and customer expectations across all sites
• Lead audits with customers and regulators and interactions with authorities
• Develop and harmonize quality systems, processes, and procedures for product quality and reliability
• Collaborate with Commercial, Operations, Product Management, Supply Chain and Regulatory to manage customer quality agreements and changes
• Establish and monitor quality metrics to drive continuous improvement
• Build and mentor a high-performing quality organization across sites
• Represent Quality on cross-functional projects and leadership forums

Skills

Quality leadership

Regulatory knowledge

Audits

Cross-functional collaboration

Education

Bachelor’s degree in science, engineering, life sciences, or related field

Job description

## Senior Director, QualityApply: Waltham, MA: Marlborough, MA: Breda, Netherlands: Full time: Posted 30+ Days Ago: R-482Make a global impact—join Repligen. We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us! As Senior Director, Quality, you will provide strategic leadership and oversight for Repligen’s global Filtration & System networks, ensuring the highest standards of quality, compliance, and customer satisfaction across all sites and functions. You will be responsible for developing, implementing, and continuously improving a robust Quality Management System that meets regulatory requirements, supports business growth, and exceeds industry standards. As a member of the Global Quality Leadership Team, reporting directly to the VP Global Quality, you will partner closely with Operations, Commercial, Product Management, Supply Chain, Regulatory Affairs, and senior business leaders to establish a culture of quality excellence, operational performance, and continuous improvement throughout the network. This role can be based in Waltham, MA (USA) or Breda, Netherlands.**Responsibilities:*** Lead and execute the quality strategy across Repligen’s Filtration & System networks, 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 forcustomer 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**Qualifications:*** 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 Filtration, Systems, 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.*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 $191,250 -260,000 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.*