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).
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
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
- 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
The estimated salary range for this role, based in the United States of America is $150,000-$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.
