Senior Client Quality Manager

Danaher•Fargo, ND

49d•Onsite

About The Position

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.

Requirements

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.).

Nice To Haves

Current or past Quality certifications a plus (e.g. ISO 9001, ASQ, etc.)
Experience in cell and therapy or biological manufacturing is a plus

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.