Supplier Quality Manager

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $124 449 - $150 803 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Bristol Myers Squibb

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1887

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Bristol Myers Squibb est une entreprise biopharmaceutique mondiale engagée dans la découverte, le développement et la distribution de médicaments innovants qui aident les patients à surmonter des maladies graves. Leurs domaines de prédilection incluent la santé cardiovasculaire, la thérapie cellulaire, l'immunologie et l'oncologie. Avec un engagement à transformer les résultats pour les patients grâce à une science de pointe, Bristol Myers Squibb collabore avec un réseau mondial de chercheurs, de prestataires de soins de santé et d'autres parties prenantes. Ils visent à être des leaders dans l'innovation pour les patients tout en favorisant la diversité et l'inclusion au sein de leur personnel.

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

🎯 Exigences

• 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%

🏖️ Avantages

• 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%