Sr Client Quality Manager
Sr Client Quality Manager
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Job Description
At Aldevron we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated forwardthinking associates share this goal by combining bestinclass 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 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 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 longterm quality customer management.
This role is onsite at our Fargo ND location.
Primary 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.
Job Qualifications
- Bachelor of Science required.
- 9 years of CDMO and (or) customerfacing experience in a Quality with experience working in a regulated or GMP compliant environment and leading projects or related experience.
- 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.
- Strong EQ
Preferred Qualifications
- Experience in cell and therapy or biological manufacturing is a plus
- Experience in cell and therapy or biological manufacturing is a plus
#LIGC1
#LIOnsite
Join our winning team today. Together well accelerate the reallife impact of tomorrows 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 .
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 accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Required Experience:
Manager
Employment Type
Full-Time
