[Hiring] Manager, Supplier Quality @Bristol Myers Squibb

Role Description

The Manager for Supplier Quality will be responsible for ensuring supplier activities are in compliance with RayzeBio policies, standards, procedures and global cGMPs to support commercial and clinical operations. In addition, the role will provide leadership of material lifecycle management, qualification, change management, non-conformance, and continuous improvement.

• Oversees the qualification and management of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) vendors.
• Identifies and assesses new vendors, develops and revises Quality Agreements, and maintains the Approved Vendor List.
• Manages site implementation of material qualification, vendor change notification, and material non-conformance programs.
• Manages the lifecycle of materials used for the manufacture of starting materials, drug substance, and drug products.
• Provides oversight and review of supplier complaints and responses.
• Conducts quality assessment of supplier change notifications and ensures actions are driven to completion.
• Supports the external supplier audit program as a team member and/or lead auditor.
• Handles discrepancy reporting, deviations and Corrective and Preventive Actions (CAPA) related to nonconforming materials or services provided by vendors.
• Performs quality reviews and approvals for functional area documents, including SOPs, technical documents, reports, agreements, qualifications, and various forms.
• Establishes and implements processes to ensure quality oversight of on-site service vendors.
• Coordinates and leads meetings with site stakeholders, other network sites, and external partners.
• Leads the team in cross-functional meetings and initiatives concerning supplier and material activities.
• Participates as a core team member in any corporate or health authority inspections.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies.
• Leads teams and cross-functional project teams and drives team performance and results.
• Applies AI to improve team execution and decision-making.
• Other QA specific responsibilities as assigned by QA management.

Qualifications

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 5 years of work experience in Quality Assurance.
• Experience in managing the quality of suppliers providing raw materials, consumables and services for finished product manufacturing is highly preferred.
• Experience with material lifecycle management is highly preferred.
• Familiarity with Quality Risk Management principles is valuable.
• Familiarity with SAP is valuable.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Physical Demands

• Regularly required to sit, reach with hands and arms, and talk or hear.
• Occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required include close vision and distance vision.
• Requires working in a laboratory environment with protective clothing, gloves, and safety glasses.
• May require occasional travel, but not more than 5%.

Work Environment

• The noise level in the work environment is usually moderate.

Benefits

• Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• Flexible Time Off (FTO) for U.S.-based exempt employees, along with 11 paid company holidays each year.
• 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays for non-exempt employees.
• Access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, and leaves of absence for various needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.