Audit Manager (GMP and Quality)

Location: Coralville, Iowa, United States; up to 20% overnight travel may be required.

Annual salary: $83,000–$105,000, plus eligibility for 10% incentive pay.

Company

hirify.global is a science and technology company that partners with customers worldwide to develop solutions for complex challenges.

What you will do

• Lead internal and external GMP and quality audit programs from planning through execution, reporting, CAPA review, effectiveness verification, and closeout.
• Monitor FDA inspectional trends, cGMP requirements, global regulatory expectations, and industry best practices.
• Coordinate audit logistics, documentation, facility tours, schedules, document repositories, subject matter experts, client communications, and audit tracking.
• Partner with cross-functional teams to identify compliance risks and support problem-solving initiatives.
• Develop corrective and preventive actions that strengthen regulatory compliance, product quality, and inspection readiness.

Requirements

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

Nice to have

• Experience leading audit programs in pharmaceutical, biotechnology, biologics, cell and gene therapy, or other highly regulated manufacturing environments.
• Experience preparing for, hosting, and responding to FDA, international regulatory, and third-party certification audits.
• Experience developing audit readiness programs, inspection preparation tools, audit documentation systems, and standardized audit processes.
• Technical knowledge of cGMP biopharmaceutical manufacturing processes.

Culture & Benefits

• Paid time off and comprehensive medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Eligibility for bonus or incentive pay at 10% ICP.
• Work supporting science and technology solutions for complex customer challenges.