Director, Quality

Repligen Corporation•Shrewsbury, MA

3d•Onsite

About The Position

We are seeking an experienced Quality Leader to join our Repligen Shrewsbury, MA facility. The Shrewsbury site includes both a manufacturing operation and distribution center, and this role will lead the Quality Operations and Incoming Quality Control teams that support both functions. The Director of Quality will oversee the site's ISO 9001 Quality Management System, build strong partnerships across the organization, and drive a culture of quality, continuous improvement, and accountability. This individual will mentor and develop a high-performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges. 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.

Requirements

Bachelor's degree in Engineering, Biology, or Chemistry required.
Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required.
Minimum of 5-8 years of experience mentoring, developing, and supervising direct reports.
Excellent verbal and written communication skills with the ability to influence and build strong working relationships across functions.
Strong attention to detail and commitment to quality and compliance.
Collaborative team player who effectively partners across departments to achieve common goals and drive business success.
Demonstrated ability to foster and sustain a Quality Culture across the organization through leadership, engagement, and accountability.
Demonstrated ability to mentor, train, coach, and develop quality professionals while building a high-performing and engaged team.

Nice To Haves

ASQ CQA and/or CQE certification preferred.
Experience with LEAN implementation strongly preferred.

Responsibilities

Maintain compliance to ISO 9001 for all aspects of the QMS including, but not limited to, Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Complaint Handling, Change Controls, and other product lifecycle management activities, while promoting a culture of quality, accountability, and continuous improvement.
Partner with cross-functional stakeholders to drive continuous improvement initiatives and support achievement of shared business objectives.
Author and revise procedures and specifications in collaboration with subject matter experts to ensure clarity, effectiveness, and regulatory compliance.
Ensure effective training and adoption of quality systems and procedures across the organization.
Foster a strong cross-functional quality mindset and influence quality ownership at all levels of the organization.
Effectively communicate sound quality guidance based on regulatory requirements, customer expectations, and business needs, balancing strategic priorities with operational execution.
Apply quality knowledge strategically and operationally across projects within a matrix environment, demonstrating strong negotiation, influence, and facilitation skills.
Demonstrate strong organizational skills with the ability to effectively multitask, prioritize, and drive results in a dynamic environment.
Adapt to changing business needs while maintaining focus on quality, compliance, and execution of key deliverables.
Exercise sound judgment, initiative, and problem-solving skills to proactively identify and address quality-related risks.
Serve as the Management Representative to the ISO 9001 registrar.
Develop, monitor, and compile quality metrics to support monthly KPI reporting and management review meetings, leveraging data to drive informed decision-making and continuous improvement.
Facilitate operational excellence initiatives within Quality Assurance to improve efficiency, effectiveness, and overall quality performance.
Maintain internal and external audit schedules and ensure audit readiness across the organization.
Maintain a risk-based strategy for overall quality compliance and continuous improvement in support of ISO 9001 requirements.
Collaborate closely with Global Supplier Quality to ensure timely investigation and remediation of supplier material issues, fostering strong internal and external partnerships.
Review and approve validation plans, deviations, failure investigations, and corrective action plans prior to implementation, ensuring appropriate risk assessment and compliance.
Assist with OOS investigations, OOT investigations, and NCMR investigations, promoting thorough root cause analysis and sustainable corrective actions.
Complete required actions associated with identified corrective and preventive actions for the Quality department in a timely and effective manner.
Lead, mentor, and develop direct reports by setting clear objectives, providing ongoing coaching and feedback, and supporting professional growth and team success.