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Supplier Compliance Manager - Devens, MA

$105.33k - $127.6k

VetJobs

Supplier Compliance Manager - Devens, MA VetJobs is seeking a Supplier Compliance Manager at Bristol Myers Squibb (BMS) with on-site requirements at the listed location. The role focuses on supplier investigations, CAPA, change control, and supplier quality processes to ensure GMP compliance and continuous improvement. Overview Position Summary: This role provides investigation support, supplier process improvement, and compliance expertise to implement supplier changes in accordance with corporate policies and GMP requirements. The candidate will collaborate with Global Quality, SQE teams, and site stakeholders to manage investigations, CAPA, change controls, and supplier performance initiatives. Responsibilities Perform investigations using the eQMS (Infinity) system for supplier complaints, including BMS and supplier processes. Create and execute Corrective Actions and Preventive Actions (CAPA). Prepare, submit, and discuss findings with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier Leads, BMS Site Supplier Quality, and SQE teams. Perform trending analysis of site events and complaints; investigate root causes of no-fault-found investigations and implement process improvements to prevent recurrence. Generate, review, and implement procedures and forms to ensure compliance with current practices or GMP trends. Support the supplier development team by preparing quarterly data for Quality Council and governance meetings. Evaluate and improve the supplier complaint investigation and material return processes. Create, evaluate, follow up, and approve change controls for the assigned site, coordinating with corporate and external parties; ensure timely closure and status updates in the quality system. Create detailed project plans using project management tools; provide training and development to suppliers to prevent recurrence of issues. Implement processes to address supplier performance deficiencies and ensure compliance with corporate/site procedures and cGMPs. Apply Lean Six Sigma tools to reduce investigations and establish corrective, preventive, and proactive actions. Provide oversight of supplier investigations, change controls, protocols, and reports in support of BMS products. Support additional projects, QMS initiatives, or standard work as needed. Communicate with SQE Team, Global Supplier Management Team, MS&T Scientists, site buyers, and site quality management; interact with senior leaders as needed. Qualifications Bachelor’s degree in Business, Science, or Engineering. Six (6) years of experience in Quality, Purchasing, or Manufacturing Technology within pharmaceutical, biologics, cell therapy, or medical device industries. Experience with investigations, change controls, CAPA, and supplier quality activities; MS/MBA/CPIM/ASQ/Lean Manufacturing/Procurement experience is a plus. Strong track record in project management and developing/implementing quality processes in a pharmaceutical environment. Excellent written and oral communication skills; ability to interface with internal and external stakeholders at all levels. Lean Six Sigma and process improvement skills; capable of selling ideas and solutions across functions. Experience with regulatory agencies (FDA, ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA, etc.). Travel approximately 10% of the time. Working Conditions No exposure to hazards or disagreeable conditions beyond standard office/clinical environments. On-site role at the specified location. Compensation The starting compensation is a range of $105,330–$127,600 plus incentive/cash and stock opportunities (based on eligibility). Final compensation is determined based on demonstrated experience. Location Devens, Massachusetts Affiliate Sponsor: Bristol Myers Squibb (BMS) #J-18808-Ljbffr VetJobs

Vacancy posted 3 days ago
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