- Maintain compliance with ISO 9001 and applicable quality requirements across all aspects of the Quality Management System, including internal and external audits, CAPA, nonconforming material management, validation activities, and document control.
- Lead, mentor, and develop direct reports, fostering a high-performing team culture built on accountability, collaboration, and continuous learning.
- Drive quality excellence initiatives that strengthen quality culture, improve organizational effectiveness, and support long-term business objectives.
- Partner with site leadership and global quality stakeholders to support the continued development and implementation of enterprise-wide quality management processes.
- Develop, monitor, analyze, and communicate quality metrics and KPIs to assess organizational quality health, identify trends, and drive data-based decision making.
- Lead or support internal and external audit programs, ensuring timely execution, effective root cause analysis, and completion of corrective and preventive actions.
- Oversee document control processes and ensure quality procedures, policies, and records remain compliant, effective, and current.
- Provide quality oversight for investigations, deviations, nonconforming materials, out-of-specification results, and CAPA activities, ensuring appropriate risk assessment and resolution.
- Identify and implement continuous improvement opportunities that increase efficiency, strengthen compliance, and enhance overall quality system effectiveness.
- Champion strategic quality projects, including digital transformation initiatives such as the transition from paper-based quality documentation and certificates to electronic quality systems.
- Collaborate effectively with cross-functional teams to support product release activities, operational priorities, and broader business initiatives.
- Utilize risk-based decision making to maintain compliance while enabling business success.
Qualifications
- Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
- Minimum of 10 years of experience within an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
- Minimum of 4 years of people leadership experience, including coaching, mentoring, and developing direct reports.
- Demonstrated expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes.
- Strong knowledge of Good Documentation Practices (GDP), root cause analysis methodologies, and quality investigation processes.
- Experience developing, tracking, and reporting quality metrics to drive performance and continuous improvement.
- Proven ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.
- Strong organizational, problem-solving, and project management skills, with the ability to balance strategic priorities and day-to-day execution.
- Experience leading quality system improvements, transformation initiatives, or digitalization projects preferred.
- Lean, continuous improvement, or operational excellence experience preferred.
- Excellent communication, collaboration, and relationship-building skills.
- Demonstrated commitment to fostering a positive quality culture and developing high-performing teams.
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 $135,000-$190,000. 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.
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.
Skills Required
- Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline
- Minimum 10 years of experience in an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment
- Minimum 4 years of people leadership experience, including coaching, mentoring, and developing direct reports
- Expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes
- Knowledge of Good Documentation Practices, root cause analysis methodologies, and quality investigation processes
- Experience developing, tracking, and reporting quality metrics to drive performance and continuous improvement
- Ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels
- Strong organizational, problem-solving, and project management skills
- Excellent communication, collaboration, and relationship-building skills
- Demonstrated commitment to fostering a positive quality culture and developing high-performing teams
- Experience leading quality system improvements, transformation initiatives, or digitalization projects
- Lean, continuous improvement, or operational excellence experience
What We Do
FRAUD ALERT: Please take note that it has come to our attention that individuals purporting to work for Repligen are reaching out to prospective job applicants using fraudulent email addresses. All legitimate communications from Repligen will be sent from an individual with an email address ending in @repligen.com. If you have any concerns that a communication may be fraudulent and you would like to confirm whether it is, you may email [email protected] and someone will respond. Repligen is a bioprocessing-focused life sciences company bringing over 40 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies. Repligen headquarters is in Waltham, Massachusetts and our manufacturing facilities are located around the world. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.
