Senior Specialist, Supplier Quality

• Quality oversight of the activities and services provided by suppliers.
• Serves as a single point of QA contact for indirect suppliers supporting CT manufacturing sites.
• Assists with supplier qualification activities of new and current suppliers.
• Initiate and Manage Supplier Quality risk assessments.
• Create / negotiate and maintain Supplier Quality Agreements.
• Work closely with the suppliers and involve SMEs to ensure proper and timely resolution.
• Evaluate and communicate supplier quality related changes.
• Participate in BMS audits at suppliers, as needed.
• Coordinate / Support Supplier Quality Vendor Changes and Supplier Issue.
• Collect supplier quality documentation necessary to support regulatory submissions.
• Hold appropriate periodic quality meetings with supplier representatives.
• Hold or actively participate in joint periodic meetings with stakeholders.
• Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system.
• Partner with stakeholders to assess overall supplier performance.
• Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
• Act as representation for Quality Operations as required, escalat critical issues to Management as appropriate.
• Author necessary quality system documents; review and update procedures for BMS Quality Management System per process ownerships.
• In partnership with the CoEx sponsor, define and execute the short‑and long‑term strategy for the assigned Center of Excellence.
• Serve as the CoEx subject matter expert, driving initiatives, continuous improvement, KPI performance.
• Create detailed plans of the CoEx activities using Project Management tools.
• Support Health Authority inspections and audits of the site.

• BS or MS or equivalent education in science, or related fields.
• Minimum 3-5 years of experience in a pharmaceutical/biopharmaceutical environment including previous QA experience – e.g. QA compliance role, Supplier Quality oversight.
• Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
• Experience in Supplier Quality oversight.
• Knowledge of cell therapy manufacturing processes and testing is a plus.
• Good knowledge of sterile products manufacturing processes and testing.
• Knowledge of aseptic manufacturing processes.
• Experience with performing/participating in risk assessment exercises.
• Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
• Excellent investigational and QA problem solving skills.
• Analytical mindset.
• Quality performance / continuous improvement oriented.
• Good understanding of batch disposition principles, aligned with QP concept and associated duties.
• Skilled in planning and organizing, building relationships, innovation management and resource allocation.
• Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
• 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.

Demonstrates expertise in Supplier Quality Oversight and Quality Assurance within the pharmaceutical and biopharmaceutical sectors, with a strong focus on cGMP compliance, risk assessment, and continuous improvement initiatives. Proficient in managing supplier quality agreements and conducting audits while effectively collaborating with cross-functional teams.

• Supplier Quality Oversight
• CGMP Knowledge
• Risk Assessment Experience
• CAPA Management
• Quality System Documentation

• Quality Assurance
• Supplier Qualification
• Change Control
• Deviations/OOS Management
• Investigations
• Analytical Skills
• Batch Disposition Principles
• Continuous Improvement
• Aseptic Manufacturing Processes
• Sterile Products Manufacturing

• Problem Solving
• Negotiation Skills
• Team Spirit
• Action-Oriented
• Customer-Focused

• Pharmaceutical Industry
• Biopharmaceutical Environment
• FDA Regulations
• EU Regulations
• JP Regulatory Requirements
• ICH Guidelines
• Cell Therapy Manufacturing

• Project Management Tools
• Quality Management System Software
• Office Software