Senior Manager, Global Supplier Quality

Responsibilities

• Lead supplier quality oversight for Systems, Process Analytics, and filtration networks
• Serve as the Marlborough site supplier quality lead, managing customer-related quality requests and feedback
• Accountable for supplier performance monitoring, SCAR assignment, auditing, qualification, and development
• Execute supplier management processes in alignment with the Global Quality Management System (QMS)
• Maintain the Global Approved Supplier List (ASL) and establish supplier governance routines, including scorecards and reviews
• Oversee supplier change control processes and review Supplier Change Notification (SCN) requests
• Establish and maintain Supplier Quality Agreements
• Partner with Procurement on Supplier Business Reviews and lead content development
• Provide on-site presence at facilities to assess operations and reinforce quality expectations

Requirements

• Bachelor’s degree in engineering, Life Sciences, or a related field
• 10–15 years of experience in Supplier Quality within life sciences, biopharma, or contract manufacturing
• 5–8 years of leadership experience, including management of direct reports
• Strong knowledge of ISO 9001 and ISO 13485
• Proven experience managing supplier quality issues, including SCARs and change notifications
• Ability to travel internationally to visit suppliers

Preferred Qualifications

• Master’s degree in a relevant field
• Experience in the bioprocessing or life sciences industry
• Knowledge of GMP standards
• Experience with Lean manufacturing methodologies and quality tools such as root cause analysis, FMEA, and statistical process controls

About the Company

Repligen is a bioprocessing innovator dedicated to helping customers make a difference in the world. Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide.