Product Quality Director

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $176.4k - $238.6k / year

⏰ Full Time

🔴 Lead

👔 Director

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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

• Champion a product team as Product Quality Leader, providing technical expertise, strategic leadership and project leadership to the Product Quality organization • Work with Product Quality staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance and other functional areas to resolve product and process quality issues • Lead product quality activities related to comparability, specifications, stability and annual product review in support of the Product Development Team • Provide scientific oversight for pivotal and/or commercial products • Review product data and own GMP documents and regulatory filing sections • Execute transactions in relevant GMP systems, including EDMQ and change control • Support regulatory audits and responses to questions • Lead a Product Quality Team, including oversight of product stability programs • Provide indirect staff management and guidance to Product Quality Team members • Provide cross-functional quality leadership and manage complex, long-term Product Development Team deliverables • Oversee specification, comparability, stability, site transfer and method transfer programs • Develop product quality impact statements for non-conformances and Product Quality-owned regulatory filing sections and responses to technical questions • Evaluate complex process and product quality data using science- and risk-based approaches • Develop patient-oriented strategies and novel solutions to complex issues • Communicate complex information to leadership, peers and regulatory agencies, including during inspections • Monitor emerging scientific and technical trends and their implications for Amgen • Mentor new and existing team members in Product Quality core skills

🎯 Requirements

• Doctorate degree and 4 years of Quality, Operations, Scientific or Manufacturing experience OR Master’s degree and 7 years of Quality, Operations, Scientific or Manufacturing experience OR Bachelor’s degree and 9 years of Quality, Operations, Scientific or Manufacturing experience • Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field • Expertise in protein and small molecule analysis and industry regulations • 8+ years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment • 6+ years working in a regulated environment (direct GMP) • 5+ years managing staff with increasing responsibilities and larger groups • 2+ years of experience as a PQL, technical professional or product champion • 1+ years of experience authoring or reviewing regulatory filings or similar regulatory documentation • 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product-impacting non-conformances • Experience in project management in support of product development • Knowledge of protein and small molecule quality, compliance and regulatory requirements • Knowledge of analytical techniques used for protein molecule product quality control • Understanding of drug substance and drug product development and manufacturing • Strong leadership and management skills • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals • Previous experience working on a cross-functional team in a matrix environment • Excellent written and verbal communication skills, including facilitation and presentation skills

🏖️ Benefits

• 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 • 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 support