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 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 long-term quality customer management. This role can be remote within the US OR 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) customer-facing 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
We believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working here can provide.The salary range for this role is $115,000-$140,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.#LI-GC1#LI-RemoteJoin 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 (https://www.dol.gov/agencies/ofccp/posters) .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 [email protected] to request accommodation.