Senior Client Quality Manager

Radiometer; Fargo (ND); On-site; USD 90,000 - 130,000; Full time

Job summary

Aldevron, a Danaher operating company, seeks a Senior Client Quality Manager to lead quality activities for client-specific product releases. The role anchors with the Quality Assurance Organization in Fargo, ND and works on-site within the client-focused team to drive continuous improvement and regulatory readiness.

You will oversee risk assessments, collaborate with QA/QC, and enable performance and safety standards across GMP-compliant processes while partnering with customers and internal

Qualifications

• Bachelor of Science required; 9+ years CDMO or customer-facing quality experience.
• Experience in regulated or GMP environments and leading projects.
• Exposure to federal inspections (FDA, ISO, etc.) and quality certifications a plus.

Responsibilities

• Provide daily management and leadership to drive excellence in quality related functions.
• Create quality core team goals aligned 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.

Skills

Quality leadership

GMP compliance

Regulatory inspections experience

Project management

Education

Bachelor of Science

Tools

FMEA

Quality by Design

CAPA

Job description

Senior Client Quality Manager

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time. Learn about the Danaher Business System which makes everything possible.

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. 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.

Responsibilities

• 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.

Essential Requirements

The essential requirements of the job include: 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.)

Preferred Experience

It would be a plus if you also possess previous experience in: Experience in cell and therapy or biological manufacturing is a plus Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology.

We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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