Sr Director Operational QA
Sr Director Operational QA
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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.
This position is part of the Quality department located in Fargo ND and will be Onsite. At Aldevron we combine bestinclass products and servicewith the ideal operating environment to lay the groundworkfor vital new discoveries worldwide. You will be a part of the Quality Assurance Department and report to the VP of Quality responsible for creating and executing on the Quality Assurance Strategy.
Job Responsibilities:
The creation implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic direction and vision as well as the tactical leadership necessary to consistently improve.
Supports the company in assuring it is operating in accordance with applicable regulations standards and guidance related to clinical and commercial activities and helps maintains positive audit results.
Serve as the sites primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality Agreements
Develop and enhance phase appropriate QMS programs that comply with industry standards for development through commercialization GMPs including but not limited to establishment of quality agreements management of lot review audit programs Implementation of QA review for Master and Executed Batch Records development and oversight of processes supporting inspection and release of incoming raw materials and implementation of inprocess quality assurance review
Oversee and manage all aspects of quality functions for quality systems Product Complaints Product Quality Review Lot Disposition (raw materials to finished Product release)
Establishes and implements metrics (process capability control charts measurement quality etc. for monitoring system effectiveness to enable sound quality decisions and to improve quality.
Provide leadership and management to direct reports including daytoday supervision performance management training and planning while leveraging team member skills and abilities to ensure goals are achieved.
Qualifications:
10 years of relevant experience in a quality position required with a minimum of 3 years in a managerial position.
Experience with final drug product manufacturing with incoming Quality Management Systems Quality Assurance and regulatory audits required.
Bachelor of Science required; life science related field preferred.
Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application required
Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics 210 211 and 610 CFR and EudraLex Vol. 4 including regulatory inspection or support experience preferred
Ability to manage priorities track progress of key projects and provide updates to leadership as required.
It would be a plus if you also possess previous experience in:
Experience working in a matrix environment.
Experience implementing and executing on cGMP Quality Strategy
#LIGC1
At Danaher we bring together science technology and operational capabilities to 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. Our global teams are pioneering whats next across Life Sciences Diagnostics Biotechnology and beyond. For more information visit www.danaher.
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:
Director
Employment Type
Full-Time
