GMP & Quality Audit Lead

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

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