Audit Manager

Integrated DNA Technologies; Coralville (IA); On-site; USD 83,000 - 105,000; Full time

Benefits offered by this job

Bonus incentive 10%

Medical/dental/vision insurance

401(k)

Job summary

Integrated DNA Technologies is seeking an experienced quality audit lead to manage GMP and quality audit programs, coordinating planning, execution, and CAPA review to ensure inspection readiness across the organization. This role requires collaboration with cross-functional teams and a strong foundation in quality systems.

The ideal candidate will have a Bachelor’s degree in Life Sciences or related field with 4+ years in a quality, compliance, or auditing role within a cGMP environment, and be

Qualifications

• Experience leading or participating in internal, external, customer, supplier, or regulatory audits and inspections (FDA, ISO, Notified Body).
• Strong knowledge of quality systems, cGMP, ICH Q10, ISO 13485, 21 CFR Part 210/211, data integrity requirements.
• Bachelor’s degree in Life Sciences, Engineering, Quality, Regulatory Affairs or related scientific discipline with 4+ years in quality/compliance/auditing in a cGMP environment.

Responsibilities

• Lead all aspects of GMP and Quality audit programs, including planning, execution, report issuance, CAPA review, effectiveness verification, and closeout.
• Coordinate audit logistics, documentation, facility tours, schedules, and client communications.
• Partner with cross-functional teams to identify compliance risks and develop corrective and preventive actions.

Skills

Auditing experience

Regulatory knowledge

Quality systems

Education

Bachelor's degree in Life Sciences/related

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:

• Ability to travel – May require overnight travel, up to 20%
• Must have a valid driver's license with an acceptable driving record

It would be a plus if you also possess previous experience in:

• 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.

• 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.

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The U.S. EEO posters are available here.

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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 [e-mail].