Senior R&D Supplier Quality Manager

🕒 October 9

🇺🇸 United States – Remote

💵 $132k - $178.6k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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