R&D Supplier Quality Manager

🕒 il y a 17 jours

🇺🇸 États-Unis – Télétravail

💵 $104 287 - $141 094 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• Support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline • Execute supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations • Oversee suppliers providing, hosting, developing, validating, maintaining, or supporting GxP computerized systems • Conduct risk-based supplier assessments, qualification, audits, and lifecycle management, including quality agreements • Lead or support qualification and ongoing oversight of suppliers using or providing GxP computerized systems, interfaces, and devices • Assess and oversee supplier AI-enabled GxP computerized systems for compliance with procedural controls, policies, and standards • Plan, lead, and document risk-based audits of supplier GxP computerized systems and quality processes • Assess supplier controls for validation, data integrity, security, access management, change and configuration management, incidents, backup, recovery, business continuity, and decommissioning • Review quality and technical requirements in supplier contracts and quality agreements • Participate in supplier governance and periodic reviews; evaluate performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness • Support inspection readiness and regulatory responses related to supplier computerized systems • Monitor supplier performance, track KPIs, and escalate quality issues • Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure • Maintain supplier data in quality systems such as Veeva and TrackWise • Engage suppliers on requirements, governance, and process improvement initiatives • Ensure procedural compliance, perform quality checks, and contribute to continuous improvement • Collaborate with R&D, Supply Chain, Sourcing, and QA teams on supplier quality strategies

🎯 Exigences

• Doctorate degree OR Master’s degree and 2 years of Science, Engineering, or experience in a related field OR Bachelor’s degree and 4 years of Science, Engineering, or experience in a related field OR Associate’s degree and 8 years of Science, Engineering, or experience in a related field OR High school diploma / GED and 10 years of Science, Engineering, or experience in a related field • Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers • Experience with supplier quality risk assessment tools and audit practices • Working knowledge of computerized system validation and assurance principles • Knowledge of risk-based system lifecycle practices and expectations for electronic records, electronic signatures, audit trails, and data integrity • Experience assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers • Ability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance data • Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring • Excellent written and verbal communication skills • Ability to work effectively in cross-functional teams and in a matrixed environment • Strong problem-solving and critical thinking abilities • Detail-oriented with a continuous improvement mindset • Proactive collaboration and relationship-building skills • Ability to manage multiple priorities and deliver results under timelines • Sponsorship for this role is not guaranteed

🏖️ Avantages

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support • Up to 10% domestic and international travel may be required for supplier engagements and audits