Executive Director - Product Quality

March 10

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

+1 more states

🏄 California – Remote 🍂 Massachusetts – Remote ⚓ Rhode Island – Remote

💵 $267.2k - $310.3k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

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Amgen

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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.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Provide strategic and technical leadership to ensure the highest standards of product quality across multiple late-phase clinical and commercial programs • Manage Directors and additional staff supporting the Product Quality work center teams responsible for deliverables for multiple late-phase clinical or commercial programs • Advise on CMC strategies and quality risk management for commercialization including strategies for in-process controls, specifications, stability, and comparability • Serve as a mandatory attendee for Product Quality-related boards and committees like the PQ Review Board • Collaborate with cross-functional leaders in Quality, Regulatory Affairs, Process Development, Manufacturing, and Supply Chain to resolve issues and advance business imperatives • Engage with and influence Executive Management, mentor and advise staff

🎯 Requirements

• Doctorate Degree & 6 years of Quality, Operations, Scientific or Manufacturing experience, OR Master's Degree & 10 years of Quality, Operations, Scientific, or Manufacturing experience, OR Bachelor's Degree & 12 years of Quality, Operations, Scientific, or Manufacturing experience • Six years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field (preferred) • Expertise in the areas of protein and small molecule analysis and industry regulations (preferred) • Ten or more years of pharmaceutical experience (preferred) • Eight or more years working in a regulated environment (direct GMP) (preferred) • Five or more years managing staff with increasing responsibilities and larger groups (preferred) • Three or more years of experience with authoring or review of regulatory filing or similar regulatory documentation (preferred) • Three or more years of experience supporting non-conformance investigations (preferred) • Previous experience engaging with regulatory bodies and external organizations (preferred) • Knowledge of protein and small molecule quality, compliance and regulatory requirements (preferred) • Understanding of drug substance and drug product development and manufacturing (preferred) • Strong leadership and management skills (preferred)

🏖️ 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. • 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 and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible.