Senior Quality Manager

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🔥 8 minutes ago

🌲 North Carolina, Ohio – Remote

🌲 North Carolina – Remote 🏈 Ohio – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• You will play a key leadership role in advancing quality, compliance, and operational excellence across the Oral Solid Dose business unit. • This role is responsible for driving continuous improvement across global sites, leading compliance initiatives, and identifying opportunities to improve efficiency, consistency, and quality system performance. • You will serve as a critical liaison between global quality functions and site quality leadership, helping to align business unit priorities with site execution. • Working closely with Site Quality Heads, operations, technical teams, regulatory, commercial, and client-facing functions, you will support the implementation of global quality strategies, strengthen inspection readiness, and promote a culture of proactive, risk-based quality management. • You will also support clients and quality heads for escalations, helping to ensure timely communication, effective issue resolution, and strong customer confidence. • You will support complex investigations, CAPA effectiveness, quality performance reviews, and cross-site improvement initiatives while leveraging Practical Process Improvement (PPI), data-driven decision-making, and standardized best practices. • You will help drive compliance maturity, share learnings across sites, and enable consistent execution of quality expectations across the global Oral Solid Dose network.

🎯 Requirements

• BS degree required • Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field • Advanced degree preferred • Professional certifications desired (ASQ, Lean Six Sigma, etc.) • Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6-8 years of experience in pharmaceutical, medical device, or regulated life sciences industry required • 5 years of quality management/leadership experience required • Experience implementing continuous improvement initiatives • Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis • Experience hosting regulatory inspections and customer audits • Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR) • Strong understanding of quality management systems and GMP requirements • Demonstrated experience leading quality investigations, CAPA, and change control processes • Excellent project management and cross-functional leadership abilities • Strong data analysis and problem-solving capabilities • Excellent written and verbal communication skills • Ability to build collaborative relationships at all levels • Proficiency with quality management software systems • Ability to travel up to 50%.

🏖️ Benefits

• We offer competitive remuneration • annual incentive plan bonus scheme • healthcare • a range of employee benefits!