Clinical Quality and GCP Complaince

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Description Overview

The Clinical Quality Assurance Professional is responsible for providing independent Quality Assurance oversight of Perrigo’s responsibilities as a clinical trial sponsor, including leading Good Clinical Practice (GCP) and applicable Good Laboratory Practice (GLP) audit activities across Perrigo’s global development portfolio. This role provides strategic oversight of GCP quality systems and sponsor oversight activities, manages the risk-based audit program, supports inspection readiness initiatives, and serves as a subject matter expert on GCP compliance and the application of regulatory requirements to sponsor activities and activities delegated to CROs and other clinical service providers.

Scope of the Role

- Plan, schedule, conduct, and manage internal and external GCP and GLP audits of Contract Service Providers (CSPs), CROs, preclinical/nonclinical CROs and test facilities, laboratories, and supporting vendors to ensure compliance with company standards and applicable global regulations.

- Conduct study-specific and process audits, including review of clinical and nonclinical study documentation, data, and records to assess compliance, data integrity, and adherence to approved protocols, procedures, and applicable regulatory requirements.

- Prepare, review, and finalize audit reports, ensuring observations and associated risks are appropriately documented; evaluate CAPA for adequacy, track commitments through closure and perform effectiveness verification when warranted.

- Lead the development, review, and maintenance of GCP Quality Agreements with CROs, and other clinical study partners.

- Maintain GCP audit metrics and deliver quality and compliance reporting to support management reviews, inspection readiness, and continuous improvement initiatives.

- Owning the Quality oversight to develop, review, and maintain SOPs and quality documents supporting GCP auditing and compliance activities.

- Manage the internal GCP audit program, including audit planning, execution, CAPA follow-up activities, and effectiveness assessments.

- Support mock inspections, regulatory inspections, and responses related to GCP studies and quality systems.

- Provide GCP compliance guidance and oversight to cross-functional stakeholders while ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements.

- Recommend and implement improvements to GCP quality systems, processes, and procedures to strengthen compliance and operational effectiveness.

- Other duties as assigned.

Experience Required

- SQA, ASQ, or Lead Auditor certification

- Experience conducting global audits across US, EU, UK, Japan, and other international regions.

- Experience with clinical service providers and supporting functions such as eCOA, computerized system validation (CSV), and data management.

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

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Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo