Audit Manager

Radiometer; Coralville (IA); On-site; USD 83,000 - 105,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Job summary

Danaher’s IDT division seeks a Quality Assurance professional to lead all aspects of GMP and quality audits, planning, execution, report issuance, CAPA reviews, and inspection closeout. You will partner with cross‑functional teams to strengthen regulatory compliance and product quality, and ensure readiness for FDA, ISO, and other regulatory inspections.

Responsibilities include coordinating audit logistics, maintaining audit documentation, and developing tools to improve efficiency while

Qualifications

• 4+ years in quality, compliance, or auditing in a cGMP environment
• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs or related field

Responsibilities

• Lead or participate in audits/inspections by FDA, ISO, Notified Bodies, or equivalent regulators
• Maintain knowledge of cGMP, ICH Q10, ISO 13485, 21 CFR 210/211, and related regulatory standards
• Ensure audit readiness and develop corrective actions with cross-functional teams
• Travel may be required up to 20% with valid driver's license

Skills

Audit leadership

Regulatory knowledge

GXP compliance

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Quality/Regulatory Affairs

Job description

In this role, you will have the opportunity to:

• Lead all aspects of the internal and external GMP and Quality audit programs, including audit planning, execution, report issuance, CAPA review, effectiveness verification, and audit closeout.
• Serve as a key quality and compliance resource by maintaining current knowledge of FDA inspectional trends, cGMP requirements, global regulatory expectations, and industry best practices, and communicating relevant updates throughout the organization.
• Coordinate audit logistics and readiness activities, including preparation of standard audit documentation, facility tours, audit schedules, document repositories, subject matter expert coordination, client communications, and audit tracking processes.
• Partner with cross-functional teams to identify compliance risks, support problem-solving initiatives, develop effective corrective and preventive actions, and strengthen regulatory compliance, product quality, and inspection readiness across the organization.

The essential requirements of the job include:

• Experience leading or participating in internal, external, customer, supplier, or regulatory audits and inspections, including FDA, ISO, Notified Body, or equivalent regulatory organizations.
• Strong knowledge of quality systems, ICH Q10, cGMP, ISO 13485, 21 CFR Part 210/211, ICH, FDA, and EU regulatory standards and guidelines, as well as management and data integrity requirements.
• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related scientific discipline with 4+ years of experience in a quality, compliance, or auditing role within a cGMP-regulated environment.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role Ability to travel – May require overnight travel, up to 20% Must have a valid driver’s license with an acceptable driving record

• Leading audit programs within pharmaceutical, biotechnology, biologics, cell and gene therapy, or other highly regulated manufacturing environments.
• Preparing for, hosting, and responding to regulatory agency inspections, including FDA, international regulatory authorities, and third-party certification audits.
• Developing audit readiness programs, inspection preparation tools, audit documentation systems, and standardized audit processes that improve organizational efficiency and regulatory compliance.
• Applying technical expertise related to the manufacturing processes of cGMP biopharmaceuticals.

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $83,000-$105,000. 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 (10% ICP). We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) 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.

Join 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. The U.S. EEO posters are available here. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here. We comply with federal and state disabled 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 [e-mail].

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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