Principal Product Quality Leader

🔥 0 minutes ago

🌐 United States, Ireland – Remote

🇺🇸 United States – Remote 🇮🇪 Ireland – Remote

💵 $138.6k - $187.6k / year

⏰ Full Time

🟠 Senior

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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 technical expertise and leadership within a Product Quality Team • Engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments • Support product filings, program improvements, and investigations associated with manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections • Support late-stage or commercial biologics products • Provide technical expertise and project support to Product Quality Teams to develop, implement, and manage strategies aligned with Product Development Team goals • Own, author, and review GMP and regulatory documents • Execute transactions in relevant GMP systems • Manage product data, including comparability assessments, annual product reviews, and product quality risk assessments • Provide cross-functional quality leadership and support deliverables for late-phase and commercial programs • Support annual product reviews, specifications, comparability and stability programs, site and method transfers, product quality impact assessments, and author Product Quality-owned regulatory filing sections and RTQs • Evaluate complex process and product quality data using science- and risk-based approaches • Develop patient-oriented strategies that account for business needs and provide novel solutions to complex issues • Interface between research, global development and manufacturing to help ensure molecules become medicines

🎯 Requirements

• Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience OR Master’s degree and 4 years of such experience OR Bachelor’s degree and 6 years of such experience OR Associate’s degree and 10 years of such experience OR High school diploma/GED and 12 years of such experience • Preferred: B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field • Preferred: 6+ years working in a regulated environment, either direct GMP or technical support, with biologic products • Preferred: 1+ year authoring or reviewing market applications, INDs, supplements, or similar regulatory documentation • Proficiency in oral and written communication of complex information to Product Quality leadership, peers, and regulatory agencies • Proficiency in cGMP and international regulatory expectations • Strong scientific data management and organization skills with attention to detail • Analytical and problem-solving skills • Ability to work effectively with global, virtual teams • High degree of initiative and self-motivation • Ability to manage multiple priorities, respond quickly to urgent requests, and meet challenging timelines • Team-oriented focus on achieving team goals

🏖️ Benefits

• A comprehensive employee benefits package • 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, including remote and hybrid work arrangements, where possible • Financial plans with opportunities to save towards retirement or other goals • Work/life balance • Career development opportunities