Senior Client Quality Manager

Regulatory Toolkit; Coralville (IA); Presencial; USD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive benefits

Descripción de la vacante

IDT, a Danaher operating company, is looking for a Senior Client Quality Manager to oversee Quality Manufacture, Testing, and Product Release for client-specific products in a GMP setting. This onsite role in Coralville, IA partners with QA and QC to drive continuous improvement and support client audits.

You will lead a cross-functional team, ensure on-time delivery and regulatory readiness. You will apply FMEA, Quality by Design, and risk management to safeguard product quality and compliance,

Formación

• Bachelor of Science required with extensive CDMO and customer-facing quality experience.
• Experience in GMP-regulated environments and leading cross-functional quality projects.
• Exposure to regulatory inspections (FDA, ISO, notified bodies) a plus.

Responsabilidades

• Provide daily management to drive excellence in quality related functions.
• Lead the Customer Focused Team to meet goals within time and budget.
• Support customer audits and develop corrective actions for deviations/quality events.
• Apply risk assessment using FMEA and QbD in line with company policies.

Conocimientos

Quality leadership

Regulatory knowledge

Project management

Audits experience

Cross-functional collaboration

Communication

Educación

Bachelor of Science

Herramientas

FMEA

Quality by Design

ISO 9001

FDA inspections

Descripción del empleo

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At IDT, 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 IDT, 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 IDT 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 Coralville, IA 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 IDT and cGMP policies, procedures, rules, and regulations.

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.

It would be a plus if you also possess previous experience in:

• Experience in cell and therapy or biological manufacturing is a plus
• Experience in cell and therapy or biological manufacturing is a plus

IDT, 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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].