Senior Auditor, Quality Assurance

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

Sr Auditor, Quality Assurance

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Onsite: Lenexa, KS

Sr Auditor, QA

We are currently seeking a Sr Auditor, Quality Assurance to join our diverse and dynamic team. As a Sr Auditor, Quality Assurance at ICON, you will play a pivotal role in providing quality oversight of GMP/CMC activities supporting clinical trials, interpreting applicable regulatory requirements, and ensuring ongoing compliance, while contributing to the advancement of innovative treatments and therapies.

What You Will Be Doing:

• Serving as the Quality Assurance releasing authority for GMP/CMC activities, including review and disposition of applicable GMP documentation and activities prior to release.
• Providing dedicated Quality Assurance oversight for GMP operations, including manufacturing, pharmacy, QC laboratory, and other CMC-related activities, as applicable.
• Reviewing and approving GMP records and quality documentation, including batch records, deviations, investigations, CAPAs, change controls, and other applicable GMP documentation.
• Ensuring GMP/CMC activities are performed in accordance with applicable GMP requirements, internal quality systems, approved procedures, and client requirements.
• Providing independent QA guidance and decision‑making support for GMP quality and compliance matters, including escalation and resolution of issues that may affect product quality or release.
• Partnering closely with Manufacturing, Pharmacy Services, QC Lab, and CMC teams to provide proactive QA oversight throughout planning and execution, rather than relying solely on retrospective review.
• Supporting inspection and audit readiness for GMP/CMC operations and driving continuous improvement of the site quality system.
• Acting as a key Quality representative for GMP/CMC operations and sponsor interactions related to quality, compliance, and release activities.
• Collaborating with cross‑functional teams to identify areas for improvement in quality assurance processes and practices.
• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
• Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.
• Contributing to the continuous improvement of quality assurance programs and initiatives.

Your profile

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
• Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.
• In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
• Strong analytical and problem‑solving skills, with the ability to identify and address complex quality issues.
• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

#LI-SB7

#LI-onsite

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here