Manager, Supplier Quality
Bristol Myers Squibb
5 days ago
On-site
Indianapolis, IN
Operations
Job Responsibilities
- Oversee qualification and management of GMP and GDP vendors (identify/assess vendors, develop/revise Quality Agreements, maintain Approved Vendor List).
- Manage site implementation of material qualification, vendor change notification, and material non-conformance programs.
- Manage lifecycle of materials for starting materials, drug substance, and drug products (qualification, maintenance, reduced testing).
- Provide oversight/review of supplier complaints and responses.
- Assess supplier change notifications and drive actions to completion via change management.
- Support external supplier audit program (team member and/or lead auditor); ensure suppliers meet regulatory, cGMP, and RayzeBio requirements; evaluate observation responses and track to closure.
- Handle discrepancy reporting, deviations, and CAPA for vendor nonconforming materials/services.
- Perform quality reviews/approvals for SOPs, technical documents, reports, agreements, qualifications, and forms.
- Implement processes for quality oversight of on-site service vendors (with Facilities & Engineering, MS&T, and QA Operations).
- Coordinate/lead meetings with site stakeholders and external partners to execute vendor/material management programs (including negotiations and dispute resolution).
- Lead cross-functional meetings/initiatives for supplier and material activities.
- Participate in corporate/health authority inspections.
- Identify/report discrepancies to management.
- Apply judgment in decisions; notify management as appropriate.
- Lead teams/cross-functional project teams; drive performance and quality initiatives; apply AI to improve execution/decision-making.
Education and Experience / Qualifications
- Bachelor’s degree in engineering or life/physical science (biology, biochemistry, chemistry) required.
- Minimum 5 years’ Quality Assurance experience.
- Preferred: experience managing quality of suppliers for finished product manufacturing; material lifecycle management; familiarity with Quality Risk Management.
- Valuable: SAP familiarity.
- Knowledge of US/EU/rest-of-world cGMP regulations and guidance.
- Demonstrated leadership, communication, writing, interpersonal skills; attention to detail; sound judgment; prioritization/organization.
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (EAP, wellbeing accounts); financial protection (401(k), disability, life insurance, etc.).
Work-life benefits (explicitly listed)
- Paid Time Off: flexible time off (unlimited, manager approval) and 11 paid national holidays for US exempt employees; or 160 hours annual paid vacation plus 11 national holidays and 3 optional holidays for certain locations/employee types.
- Oversee qualification and management of GMP and GDP vendors (identify/assess vendors, develop/revise Quality Agreements, maintain Approved Vendor List).
- Manage site implementation of material qualification, vendor change notification, and material non-conformance programs.
- Manage lifecycle of materials for starting materials, drug substance, and drug products (qualification, maintenance, reduced testing).
- Provide oversight/review of supplier complaints and responses.
- Assess supplier change notifications and drive actions to completion via change management.
- Support external supplier audit program (team member and/or lead auditor); ensure suppliers meet regulatory, cGMP, and RayzeBio requirements; evaluate observation responses and track to closure.
- Handle discrepancy reporting, deviations, and CAPA for vendor nonconforming materials/services.
- Perform quality reviews/approvals for SOPs, technical documents, reports, agreements, qualifications, and forms.
- Implement processes for quality oversight of on-site service vendors (with Facilities & Engineering, MS&T, and QA Operations).
- Coordinate/lead meetings with site stakeholders and external partners to execute vendor/material management programs (including negotiations and dispute resolution).
- Lead cross-functional meetings/initiatives for supplier and material activities.
- Participate in corporate/health authority inspections.
- Identify/report discrepancies to management.
- Apply judgment in decisions; notify management as appropriate.
- Lead teams/cross-functional project teams; drive performance and quality initiatives; apply AI to improve execution/decision-making.
Education and Experience / Qualifications
- Bachelor’s degree in engineering or life/physical science (biology, biochemistry, chemistry) required.
- Minimum 5 years’ Quality Assurance experience.
- Preferred: experience managing quality of suppliers for finished product manufacturing; material lifecycle management; familiarity with Quality Risk Management.
- Valuable: SAP familiarity.
- Knowledge of US/EU/rest-of-world cGMP regulations and guidance.
- Demonstrated leadership, communication, writing, interpersonal skills; attention to detail; sound judgment; prioritization/organization.
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (EAP, wellbeing accounts); financial protection (401(k), disability, life insurance, etc.).
Work-life benefits (explicitly listed)
- Paid Time Off: flexible time off (unlimited, manager approval) and 11 paid national holidays for US exempt employees; or 160 hours annual paid vacation plus 11 national holidays and 3 optional holidays for certain locations/employee types.