Sr. Specialist, Supplier Quality

About the role

Bristol Myers Squibb is seeking a Quality Operations Specialist to oversee supplier quality activities and support clinical and commercial manufacturing activities. This role involves supplier qualification, risk assessments, and compliance with regulatory requirements.

Responsibilities

• Quality oversight of supplier activities and services
• Serve as a single point of QA contact for indirect suppliers
• Assist with supplier qualification activities
• Create and manage Supplier Quality Agreements
• Manage Supplier Quality risk assessments
• Resolve supplier-related issues, including SCARs, Deviations, Complaint investigations, and CAPAs
• Communicate supplier quality changes and ensure proper documentation
• Participate in BMS audits at suppliers
• Coordinate Supplier Quality Vendor Changes and Supplier Issues
• Support regulatory submissions with supplier quality documentation
• Hold periodic quality meetings with suppliers
• Participate in Health Authority inspections and audits
• Support QA colleagues and Quality/Supply Chain Management
• Initiate and assess Change Control, complaints, deviations/OOS, and CAPA management
• Partner with stakeholders to assess supplier performance and develop mitigation plans
• Define and execute short- and long-term strategies for the assigned Center of Excellence
• Drive initiatives, continuous improvement, and accountability for CoEx processes
• Author necessary quality system documents and procedures
• Make independent decisions and work under minimal supervision
• Work with cross-functional teams and partners worldwide

Qualifications & Experience

• BS or MS in Science or related fields, or equivalent experience
• Minimum 3-5 years of experience in a pharmaceutical/biopharmaceutical environment, including QA experience
• Thorough knowledge of cGMP, FDA, EU, and JP regulatory requirements, ICH guidelines
• Experience in Supplier Quality oversight
• Knowledge of cell therapy and sterile products manufacturing processes
• Experience with risk assessment exercises
• Core quality processes knowledge (change control, deviations/OOS, CAPA management, investigations, APR-PQR)
• Excellent problem-solving skills, analytical mindset, and ability to drive science-based decisions
• Quality performance and continuous improvement orientation
• Understanding of batch disposition principles and liaison with Health Authorities
• Planning, organizing, relationship-building, innovation management, and resource allocation skills
• Team spirit, action-oriented, and customer-focused
• Negotiation and persuasion skills
• Good knowledge of most common office software
• Good verbal and written communication skills in English
• Up to 10% travel

Benefits

Our benefits package includes health coverage, wellbeing support, financial well-being and protection, and work-life benefits. Additional incentive cash and stock opportunities may be available based on eligibility. For more details, visit careers.bms.com/working-with-us.