Senior Manager, Quality

Responsibilities

• Provide strategic direction and leadership for the site Quality organization, including QC, QA, and Compliance.
• Serve as the primary Quality authority at the site, accountable for performance, risk management, and compliance posture.
• Own and continuously enhance the site’s QMS to ensure compliance with ISO 9001, GMP, and global regulatory requirements.
• Act as the primary site representative for regulatory inspections, customer audits, and external agency interactions.
• Ensure robust governance of controlled environments, including ISO 7 and ISO 8 cleanroom operations.
• Maintain ultimate accountability for product quality, disposition decisions, and batch release compliance.
• Partner with Manufacturing, Engineering, and Supply Chain to embed quality into all operational processes.
• Lead major quality events, recalls, or regulatory escalations.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 8-10 years of progressive Quality experience within regulated industries such as biopharma, medical device, or life sciences.
• Significant leadership experience managing multi-functional Quality organizations in a manufacturing environment.
• Deep expertise in QMS, regulatory compliance, and quality risk management.
• Proven experience with ISO 9001, GMP, and cleanroom operations.
• Demonstrated success leading through regulatory inspections and complex customer interactions.

Preferred Qualifications

• Advanced degree (MS, MBA, or equivalent).
• Experience with gamma irradiation and X-ray sterilization, including supplier oversight and dose validation.
• Experience with enterprise systems such as Salesforce and SAP.
• Familiarity with BPOG guidance and customer communication alignment.

About the Company

Repligen is a global leader in bioprocessing, dedicated to inspiring advances in the production of biologic drugs that improve human health worldwide. We provide innovative technologies and solutions that help set new standards in bioprocessing, fostering a culture of purpose, collaboration, and shared success.