Senior Client Quality Manager
Danaher Corporation
Summary
The Senior Client Quality Manager is responsible for overseeing all duties related to the Quality Manufacture, Testing, and Product Release of Client specific Product(s) to support our core clients. This individual will also partner with Quality Assurance and Quality Control departments to support all Quality related activities and drive continuous process improvement into the associated processes and procedures. This individual will also help to plan, direct, and coordinate activities of the Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and within budget. The successful individual will drive project success to provide Aldevron with a competitive advantage in long-term quality customer management.
Job description
This position reports to the Director of Client Quality and is part of the Quality Assurance Organization located in Fargo, ND and will be an on-site role.
In this role, you will have the opportunity to:
- Provide daily management and leadership to drive excellence in quality related functions.
- Create quality core team goals and objectives in alignment with Customer Focused Team goals and customer requirements.
- Partner with Quality leadership to facilitate the daily quality team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement.
- Provide support for customer audits, visits and conference calls. Work with Customer Focused Team to develop systemic corrective actions to any deviations / Quality Events noted or discovered.
- Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design in compliance with Aldevron and cGMP policies, procedures, rules, and regulations.
Requirements
- Bachelor of Science, required.
- 9+ years of CDMO and (or) customer-facing experience in a Quality with experience working in a regulated or GMP compliant environment and leading projects.
- Exposure to regulatory agency inspections or other types of audits (e.g., FDA, notified bodies, ISO, etc.).
- Current or past Quality certifications a plus (e.g. ISO 9001, ASQ, etc.)
- Experience in cell and therapy or biological manufacturing is a plus
Benefits
- Health care program
- Paid time off
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.