Senior R&D Supplier Quality Manager

🕒 il y a 17 jours

🇺🇸 États-Unis – Télétravail

💵 $132 037 - $178 638 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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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

• Provide risk-based Quality governance and oversight for R&D suppliers • Support and facilitate a cross-functional R&D and Operations forum for clinical quality issues • Coordinate intake and risk-based triage of complex clinical supplier and Quality issues • Identify applicable requirements, potential Quality and business risks, subject matter experts, and accountable functions • Partner with Quality and business stakeholders to establish supplier qualification and oversight strategies • Support development, negotiation, and maintenance of Quality Agreements and supplier Quality requirements • Collaborate with research and other functions on continuous improvement initiatives • Act as Quality lead for quality records related to R&D Supplier management • Define and maintain R&D Supplier Quality KPIs and metrics • Drive escalation, documentation, and continuous improvement for supplier-quality risks • Coordinate across multiple functions and time zones in a global, matrixed organization

🎯 Exigences

• Doctorate degree and 2 years of Quality Management or other relevant experience OR Master’s degree and 4 years OR Bachelor’s degree and 6 years OR Associate’s degree and 10 years OR high school diploma/GED and 12 years • Experience in supplier quality management or oversight • Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends • Experience in clinical supply chain Quality or oversight of GMP/GDP-regulated services used in clinical development • Practical experience applying GMP and/or GDP requirements within a regulated life sciences environment • Ability to influence and drive progress across functions • Effective decision-making and influencing skills • Strong leadership, negotiation, critical thinking, and analytical skills • Written and verbal communication skills • Ability to use tools and systems supporting supplier quality management processes • Excellent project management abilities • Experience in a global, matrix organization across multiple time zones • Experience supporting supplier quality oversight across complex, cross-functional, or global environments • Experience in contract negotiations and supplier/service-provider relationship building • Experience in transactional lean and value stream mapping • Ability to adapt to changing business needs and navigate ambiguity • Willingness and capability to travel up to 15% • Sponsorship is not guaranteed

🏖️ Avantages

• Health and welfare plans for staff and eligible dependents • 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 • Financial plans with opportunities to save towards retirement or other goals • Work/life balance