Senior Manager, Global Supplier Quality

RepliGen Corporation•Marlborough, MA

2d•$150,000 - $190,000•Onsite

About The Position

The Senior Manager, Supplier Quality is responsible for leading supplier Quality oversight for the Systems, Process Analytics, and filtration networks. This role also serves 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).

Requirements

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
Ability 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
Must be able to Travel to visit Suppliers, including international travel

Responsibilities

Primary Supplier Quality leader providing support for Systems, Process Analytics, and filtration networks suppliers.
Accountable for Supplier performance monitoring, SCAR assignment, auditing, Supplier qualification & supplier development
Execute Supplier Management processes in line with Repligen Global QMS requirements
Support maintenance of the Global Approved Supplier List (ASL)
Establish and maintain supplier governance routines, including performance scorecards, reviews, and escalation mechanisms to ensure sustained control of supplier performance, risk, and continuous improvement
Oversight of supplier change control processes, including timely review & processing of Supplier Change Notification (SCNs) requests in collaboration with the applicable Repligen Change Control teams
Establish & maintain Supplier Quality Agreements
Influence cross-functional teams to ensure timely execution of quality related actions requiring their support
On-site presence at facilities to assess operations, reinforce quality expectations, and ensure effective implementation of quality systems and controls
Partner with Procurement on Supplier Business Reviews, leading development & presentation of content