Senior Manager, Quality

Repligen Corp; Marlborough (MA); On-site; USD 135,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision benefits

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corp is seeking a Senior Manager, Quality in Marlborough, MA to strengthen quality systems and drive continuous improvement across functions. You will lead quality programs, mentor teams, and partner with global quality stakeholders to implement enterprise-wide processes and data-driven decisions.

The role emphasizes governance of CAPA, audits, governance of documentation, and key metrics. A strong leadership track record and hands-on experience in ISO-regulated environments are

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or related field.
• Minimum of 10 years in ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
• Minimum 4 years of people leadership experience with coaching and developing direct reports.
• Strong expertise in QMS, auditing, CAPA, document control, validation, and nonconforming materials processes.
• Knowledge of GDP, root cause analysis methodologies, and quality investigations.

Responsibilities

• Maintain ISO 9001 compliance and audits across the Quality Management System.
• Lead, mentor, and develop direct reports to build a high-performing team.
• Drive quality excellence initiatives to strengthen culture and operational effectiveness.
• Collaborate with site leadership and global quality stakeholders to advance enterprise-wide processes.
• Develop, monitor, and report quality metrics and KPIs to drive data-based decisions.
• Oversee audits, CAPA, investigations, deviations, and risk assessments as needed.
• Support digital transformation of quality documentation and electronic systems.
• Enable product release activities and cross-functional priorities with quality input.

Skills

Quality Management Systems

Auditing

CAPA

Document control

Validation

Nonconforming materials

GDP

Root cause analysis

Quality metrics

Cross-functional leadership

Lean / Continuous improvement

Digital transformation

Education

Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline

Job description

The Senior Manager, Quality is a leadership role focused on strengthening quality systems, driving continuous improvement, and supporting a culture of quality across the Marlborough site. Working across functions and partnering with global quality teams, this role will lead key quality programs, use metrics to identify opportunities for improvement, and help advance initiatives that enhance compliance, efficiency, and the overall employee and customer experience.

Responsibilities

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

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.

Compensation

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.

Thank you for your interest in Repligen! Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing — and to help our customers make a difference in the world.