Manager, Supplier Quality

Bristol Myers Squibb • Indianapolis, IN

2d • $124,449 - $150,803

About The Position

The Manager for Supplier Quality ensures supplier activities comply with RayzeBio policies, standards, procedures, and global cGMPs in support of commercial and clinical operations. The role leads material lifecycle management, qualification, change management, non-conformance, and continuous improvement. It also provides quality oversight of suppliers, materials, and on-site service vendors while partnering with internal teams and external organizations.

Requirements

• At least a bachelor's degree in engineering or a related life or physical science field, including biology, biochemistry, or chemistry.
• At least 5 years of work experience in Quality Assurance.
• Knowledge of U.S., EU, and rest-of-world cGMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent written and oral communication skills.
• Previous work responsibility requiring a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Nice To Haves

• Experience managing the quality of suppliers providing raw materials, consumables, and services for finished product manufacturing.
• Experience with material lifecycle management.
• Familiarity with Quality Risk Management principles.
• Familiarity with SAP.

Responsibilities

• Oversee qualification and management of GMP and GDP vendors, including identifying and assessing new vendors, developing and revising Quality Agreements, and maintaining the Approved Vendor List.
• Manage site implementation of material qualification, vendor change notification, and material non-conformance programs.
• Manage the lifecycle of materials used to manufacture starting materials, drug substance, and drug products, including qualification, maintenance, and reduced testing.
• Provide oversight and review of supplier complaints and responses.
• Assess supplier change notifications and drive resulting actions to completion through change management programs.
• Support the external supplier audit program as a team member and/or lead auditor; assess supplier systems against regulatory, cGMP, and RayzeBio requirements, and track observation responses and follow-up actions through closure.
• Handle discrepancy reporting, deviations, and CAPAs related to nonconforming materials or vendor-provided services.
• Review and approve functional-area documents, including SOPs, technical documents, reports, agreements, qualifications, and forms.
• Establish and implement processes for quality oversight of on-site service vendors in collaboration with Facilities & Engineering, MS&T, and QA Operations.
• Coordinate and lead meetings with site stakeholders, network sites, and external partners to execute vendor and material management programs, including discussions, negotiations, and dispute resolution.
• Lead cross-functional meetings and initiatives concerning supplier and material activities.
• Participate as a core team member in corporate or health authority inspections.
• Identify and report discrepancies from required work practices or procedures to management.
• Make sound decisions within defined practices and policies and notify management as appropriate.
• Lead teams and cross-functional project teams, drive team performance and results, and contribute to departmental performance and quality initiatives.
• Apply AI to improve team execution and decision-making.
• Perform other QA-specific responsibilities as assigned by QA management.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Eligible U.S.-based exempt employees receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
• May be eligible for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager