Manager of Global Audits

Manager of Global Audits

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology? At Aldevron, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact. Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether youre launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potentialone discovery at a time.

The Manager of Global Audits is responsible for maintaining the internal and external audit programs in compliance with all domestic and foreign quality regulatory expectations. This position will ensure auditors have the education, experience, and / or training vital to be able to identify compliance issues and find resolution in a highly autonomous manner. This position reports to the Sr. Director of Regulatory and is part of the Regulatory and Audit department located in Fargo, ND and will be onsite. In this role, you will have the opportunity to :

• Manage Audit Programs : Plan, execute, and oversee internal and external GMP and Quality audits. Ensure timely completion of audit reports and effective follow-up on corrective actions to maintain compliance and audit readiness.
• Ensure Regulatory Compliance and Expertise : Maintain deep knowledge of applicable regulations and standards (e.g., 21 CFR, EudraLex, ISO, ICH, WHO). Provide expert interpretation of cGMPs and regulatory expectations to internal stakeholders.
• Quality Oversight of Materials and Specifications : Oversee quality aspects of material onboarding, including specification development and compliance tracking, ensuring alignment with regulatory and internal quality requirements.
• Training, Development, and Succession Planning : Lead the training, coaching, and development of auditing personnel. Maintain a robust qualification program and support succession and business continuity planning.
• Regulatory Communication and Documentation : Draft, review, and finalize responses to regulatory authorities and clients in collaboration with senior leadership. Monitor and communicate industry trends and regulatory developments.
• Leadership and Team Management : Provide strategic direction and mentorship to the audit team. Foster a culture of accountability, quality, and continuous improvement aligned with GxP principles.
• Stakeholder Engagement and Collaboration : Build and maintain strong relationships with internal departments and cross-functional teams. Ensure effective communication and collaboration to support quality objectives.

The essential requirements of the job include : Bachelors degree in Life Sciences, Pharmacy, or related field; 5+ years of experience in Quality Assurance or Regulatory Compliance within a GMP-regulated environment with at least 2+ years in a leadership or audit management role; in-depth knowledge of global regulatory requirements and quality systems; experience with internal, external or regulatory audits and inspections; strong communication, leadership, and project management skills.

Travel, Motor Vehicle Record & Physical / Environment Requirements : Ability to travel 20% of the time.

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 comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and / or to receive other benefits and privileges of employment, please contact : 1-202-419-7762 or applyassistance@danaher.com.