Senior Manager, Global Supplier Quality

Responsibilities

• Leading supplier Quality oversight for the Systems, Process Analytics, and filtration networks.
• Serving as the Marlborough site supplier Quality lead ensuring customer-related Quality requests and feedback are timely managed through collaboration with Global Quality contacts in alignment with Repligen’s Global Quality Management System (QMS).
• Providing support for Systems, Process Analytics, and filtration networks suppliers.
• Accountable for Supplier performance monitoring, SCAR assignment, auditing, Supplier qualification & supplier development.
• Executing Supplier Management processes in line with Repligen Global QMS requirements.
• Maintaining the Global Approved Supplier List (ASL).
• Establishing and maintaining supplier governance routines, including performance scorecards, reviews, and escalation mechanisms to ensure sustained control of supplier performance, risk, and continuous improvement.
• Overseeing supplier change control processes, including timely review & processing of Supplier Change Notification (SCNs) requests in collaboration with the applicable Repligen Change Control teams.
• Establishing and maintaining Supplier Quality Agreements.
• Partnering with Procurement on Supplier Business Reviews, leading development & presentation of content.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related field required, master’s preferred.
• 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 resources.
• Bioprocessing and/or life sciences industry experience strongly preferred.
• Strong knowledge of ISO 9001,13485 (GMP desirable).
• Experience of leading Supplier Qualification, development, auditing, and supplier performance management.
• Experience managing supplier quality issues, including SCARs, and change notifications.
• Able to lead Supplier Quality activities across multiple Suppliers, sites, and regions.
• Strong analytical, communication, and problem-solving skills.
• Experience of Lean manufacturing methodologies & quality tools such as root cause analysis, FMEA, statistical process controls.