Product Quality Associate Director

🔥 13 hours ago

🌐 United States, Ireland – Remote

🇺🇸 United States – Remote 🇮🇪 Ireland – Remote

💵 $145.2k - $196.5k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 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 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 product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections • Serve as the accountable Product Quality Leader representing Quality on Product Delivery Teams for late-stage or commercial biologics products • Develop, implement, and manage strategies to meet Product Delivery 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 • Define Product Quality deliverables and timelines across Product Delivery Teams • Coordinate discussions and lead decision-making for Product Quality strategies and activities • Lead activities across Product Quality teams and cross-functional subject matter experts • Provide cross-functional Quality leadership and influence program deliverables for late-phase and commercial programs • Support annual product reviews, specifications, comparability and stability programs, site and method transfers, and product quality impact assessments • Author Product Quality-owned regulatory filing sections and responses to questions • Provide subject matter expertise and strategic influence for 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

🎯 Requirements

• Doctorate degree and 3 years of Quality, Operations, Scientific, or Manufacturing experience OR Master’s degree and 5 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor’s degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience OR Associate’s degree and 12 years of Quality, Operations, Scientific, or Manufacturing experience OR High school diploma / GED and 14 years of Quality, Operations, Scientific, or Manufacturing 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 with authoring or review of 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 successfully, react quickly to address urgent requests and meet challenging timelines • Team-oriented, with a focus on achieving team goals • Sponsorship for this role is not guaranteed

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support