Senior QA Auditor – GMP/CMC Lead (Onsite Lenexa)

KCR Placement; Lenexa (KS); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning options

Employee Assistance Programme (LifeWor

Life assurance

Flexible country-specific benefits

Job summary

ICON is a global healthcare intelligence and clinical research organisation committed to advancing medicines and therapies. The Sr Auditor, Quality Assurance will provide quality oversight of GMP/CMC activities, interpret regulatory requirements, and ensure ongoing compliance to support clinical trials.

The role involves releasing authority, cross-functional QA support, and driving continuous improvement of the site quality system, including readiness for inspections and sponsor interactions.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
• 7+ years in quality assurance within pharma/biotech/CRO with leadership
• Strong knowledge of regulatory requirements (ICH-GCP, FDA) and quality systems

Responsibilities

• Serving as QA releasing authority for GMP/CMC activities and disposition of documentation.
• Providing QA oversight for GMP operations including manufacturing, pharmacy, QC lab.
• Reviewing and approving GMP records, deviations, investigations, CAPAs, changes, and related docs.
• Ensuring activities comply with GMP requirements, internal systems, and client requirements.
• Providing QA guidance and decision-making support for quality and compliance matters.
• Collaborating with Manufacturing, Pharmacy, QC Lab and CMC teams for proactive QA oversight.

Skills

QA oversight

GMP knowledge

Regulatory knowledge

Issue resolution

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

GMP documentation

CAPA system

Job description

ICON is a global healthcare intelligence and clinical research organisation committed to advancing medicines and therapies. The Sr Auditor, Quality Assurance will provide quality oversight of GMP/CMC activities, interpret regulatory requirements, and ensure ongoing compliance to support clinical trials.

The role involves releasing authority, cross-functional QA support, and driving continuous improvement of the site quality system, including readiness for inspections and sponsor interactions.