Supplier Quality Manager

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $124.4k - $150.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Ensure supplier activities comply with RayzeBio policies, standards, procedures, and global cGMPs • Lead material lifecycle management, qualification, change management, non-conformance, and continuous improvement • Oversee qualification and management of GMP and GDP vendors • Identify and assess new vendors, develop and revise Quality Agreements, and maintain 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 • Provide oversight and review of supplier complaints and responses • Conduct quality assessments of supplier change notifications and drive actions to completion • Support and lead external supplier audits and ensure supplier systems meet regulatory, cGMP, and RayzeBio requirements • Evaluate observation responses, track follow-up actions, and bring them to closure • Handle discrepancy reporting, deviations, and CAPAs related to nonconforming vendor materials or services • Review and approve SOPs, technical documents, reports, agreements, qualifications, and forms • Establish and implement quality oversight processes for on-site service vendors • Coordinate meetings with site stakeholders, network sites, and external partners, 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 to management • Lead teams and cross-functional project teams and drive performance and results • Contribute to departmental performance and quality initiatives • Apply AI to improve team execution and decision-making • Perform other QA responsibilities assigned by QA management

🎯 Requirements

• At minimum, a bachelor's degree in engineering or a life or physical science related field, including biology, biochemistry, or chemistry • Minimum 5 years of work experience in Quality Assurance • Experience 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 • 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 • Ability to work in a laboratory environment with protective clothing, gloves, and safety glasses while handling radioactive materials • Ability to occasionally lift and/or move up to 25 pounds • Ability to travel occasionally, not more than 5%

🏖️ Benefits

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • 3 optional holidays • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year • Summer hours flexibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs • Annual Global Shutdown between Christmas Day and New Year's Day • Reasonable workplace accommodations/adjustments and ongoing support • Occasional travel of not more than 5%