Manager, Supplier Quality

Bristol Myers Squibb; EUA; Teletrabalho; USD 124 000 - 151 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible Time Off

Stock opportunities

Discretionary incentive cash

Resumo da oferta

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Manager for Supplier Quality to ensure supplier activities align with RayzeBio policies and global cGMPs, supporting commercial and clinical operations. Lead material qualification, change management, non-conformance, and continuous improvement with cross-functional teams.

The role requires a bachelor’s degree in engineering or life/physical sciences and at least 5 years in QA, with SAP familiarity and knowledge of US/EU

Qualificações

• At minimum, a bachelor's degree in engineering or a life or physical science related field 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.
• 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.

Responsabilidades

• Oversees the qualification and management of GMP and GDP vendors and maintains the Approved Vendor List.
• Manages site implementation of material qualification, vendor change notifications, and material non-conformance programs.
• Manage the lifecycle of materials used for manufacture of starting materials, drug substance, and drug products.
• Provides oversight and review of supplier complaints and responses.
• Conduct quality assessment of supplier change notifications and ensure actions are driven to completion.
• Support the external supplier audit program as a team member or lead auditor.
• Ensure suppliers have quality and production systems meeting regulatory, cGMP and RayzeBio requirements.
• Evaluate observation responses and track closure actions.
• Handle discrepancy reporting, deviations and CAPA related to nonconforming materials or services.
• Perform quality reviews and approvals for SOPs, technical documents, reports and agreements.
• Establish and implement processes to ensure quality oversight of on-site service vendors.
• Coordinate and lead meetings with stakeholders to execute vendor and material management programs.
• Lead cross-functional project teams and drive performance and results.
• Participate as a core team member in corporate or health authority inspections.
• Identify and report discrepancies from required work practices to management.
• Apply AI to improve team execution and decision-making.

Conhecimentos

Quality Assurance

Leadership

Regulatory knowledge

Attention to detail

Communication skills

Formação académica

Bachelor's degree in engineering or life/physical science

Ferramentas

SAP

Descrição da oferta de emprego

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

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.

Job Responsibilities

• Oversees the qualification and management of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) vendors. This includes identifying and assessing new vendors, developing and revising Quality Agreements, and maintaining the Approved Vendor List.
• Manages site implementation of material qualification, vendor change notification, and material non-conformance programs.
• Manage the lifecycle of materials used for the manufacture of starting materials, drug substance, and drug products, which involves material qualification, maintenance, and reduced testing.
• Provides oversight and review of supplier complaints and responses
• Conduct quality assessment of supplier change notifications and ensure actions are driven to completion utilizing change management programs.
• Support the external supplier audit program as a team member and/or lead auditor.
• Ensure that suppliers have quality and production systems that meet applicable regulatory, cGMP and RayzeBio requirements.
• Evaluate observation responses, track responses and follow up actions to closure.
• Handle discrepancy reporting, deviations and Corrective and Preventive Actions (CAPA) related to nonconforming materials or services provided by vendors.
• Perform quality reviews and approvals for functional area documents, including Standard Operation Procedures (SOPs), technical documents, reports, agreements, qualifications, and various forms.
• Establishes and implement processes to ensure quality oversight of on-site service vendors, collaborating closely with Facilities & Engineering, MS&T, and QA Operations.
• Coordinate and lead meetings with site stakeholders, other network sites, and external partners to execute vendor and material management programs, including discussions, negotiations, and dispute resolution.
• Lead 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 and applies appropriate notification to management as appropriate.
• Leads teams and cross-functional project teams and drives team performance and results.
• Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.
• Applies AI to improve team execution and decision‑making
• Other QA specific responsibilities as assigned by QA management

Education and Experience

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

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials. The position may require occasional travel, but not more than 5%.

Work Environment

The noise level in the work environment is usually moderate.

Compensation Overview

• Indianapolis - RayzeBio - IN: $124,449 - $150,803
• Remote - United States - US: $124,449 - $150,803

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. 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, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.