Principal Product Quality Leader

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $138.6k - $187.6k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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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 late-stage or commercial biologics products • Develop, implement and manage strategies to meet 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 program deliverables for late-phase and commercial programs • Support annual product reviews, specifications, comparability and stability programs, site and method transfers, product quality impact assessments, PQ-owned regulatory filing sections and RTQs • Perform science- and risk-based evaluation of complex process and product quality data • Develop patient-oriented strategies accounting for business needs and provide novel solutions to complex issues • Collaborate at the interface of research, global development and manufacturing to support development of 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 • B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field preferred • Experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment preferred • 6+ years working in a regulated environment with experience working with biologic products preferred • 1+ year experience authoring or reviewing market applications, IND, supplements or similar regulatory documentation preferred • Proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies • Knowledge of 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, react quickly to urgent requests, and meet challenging timelines • Team-oriented focus on achieving team goals • Sponsorship for this role is not guaranteed

🏖️ Benefits

• 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 where possible • Career development opportunities • Work/life balance support • Financial plans with opportunities to save towards retirement or other goals