- Manage and host client audits to ensure that client audit needs and expectations are met and that Aldevron is approved as a Supplier for both new and ongoing business.
- Plan, lead, perform/host, and closeout client audits.
- Present each audit observation to site leadership in recurring Review Boards.
- Writes, assembles, reviews, and seek approval of audit responses by management before submitting to any client.
- Track and trend audit observations and present to management on a continual basis.
- 6+ years of experience in Quality, Regulatory, Compliance, leading audits and or validation is required.
- Bachelor's degree, or equivalent, is required. Advanced degrees (eg, MS, PhD, JD, MD) are preferred.
- Demonstrated, effective Customer Service, Project Management, and Communication skills are a must.
- Previous work experience within a CGMP or regulated environment.
- Previous work experience in a customer facing role.
- CGMP-compliant Contract Manufacturing Organizations in advanced therapies are preferred.
- Experience with hosting and/or supporting regulatory inspections (FDA, MHRA, EMA, etc).
- Qualified as an Quality/GXP Auditor by a third party.
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Audit Manager - Fargo, United States - Danaher Corporation
Description
Audit Manager, Regulatory Affairs & Compliance
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.
This position is part of the Regulatory Affairs & Compliance department located in Fargo, ND and will be onsite with some travel. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Regulatory Affairs & Compliance team and report to Regulatory Affairs & Compliance management responsible for planning, developing, and executing domestic and international regulatory compliance strategies related to statutory expectations and guidance documentation.
In this role, you will have the opportunity to:
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.
