Sr. Client Quality Manager

Aldevron; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

Aldevron is seeking a Sr. Client Quality Manager to oversee quality-related duties for client-specific products. This remote role requires leadership in quality assurance and continuous improvement, with frequent travel to Fargo, ND. The ideal candidate will have extensive experience in a regulated environment and strong emotional intelligence.

Qualifications

• 9+ years of experience in quality within a regulated environment.
• Exposure to regulatory agency inspections or audits.

Responsibilities

• Oversee Quality Manufacture, Testing, and Product Release.
• Drive excellence in quality-related functions.
• Support customer audits and develop corrective actions.

Skills

Emotional Intelligence

Education

Bachelor of Science

Job description

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or you are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development, and delivery of solutions that safeguard and improve human health.

The Sr. 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 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. Additionally, this role involves planning, directing, and coordinating activities of the Customer Focused Team to ensure that goals are achieved within prescribed time frames and budgets. The successful candidate will drive project success to provide Aldevron with a competitive advantage in long-term quality customer management.

This role is remote but requires frequent travel to our Fargo, ND location.

Primary Responsibilities

1. Provide daily management and leadership to drive excellence in quality-related functions.
2. Create quality core team goals and objectives aligned with Customer Focused Team goals and customer requirements.
3. Partner with Quality leadership to facilitate daily team performance, ensuring goals are met, and fostering a culture of safety, quality, performance, customer service, and continuous improvement.
4. Support customer audits, visits, and conference calls. Work with the Customer Focused Team to develop systemic corrective actions for any deviations or quality events noted or discovered.
5. Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design, ensuring compliance with Aldevron and cGMP policies, procedures, rules, and regulations.

Job Qualifications

1. Bachelor of Science degree required.
2. 9+ years of CDMO and/or customer-facing experience in quality within a regulated or GMP-compliant environment, including project leadership or related experience.
3. Exposure to regulatory agency inspections or audits (e.g., FDA, notified bodies, ISO).
4. Current or past quality certifications (e.g., ISO 9001, ASQ) are a plus.
5. Strong emotional intelligence (EQ).

Preferred Qualifications

1. Experience in cell and therapy or biological manufacturing is a plus.

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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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application or interview process, perform crucial job functions, and receive other employment benefits and privileges. Please contact us at [e-mail] to request accommodation.