Clinical Quality and GCP Complaince

Perrigo•Allegan Township, MI

About The Position

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

Requirements

SQA, ASQ, or Lead Auditor certification.
Experience conducting global audits across the 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.

Responsibilities

Plan, schedule, conduct, and manage internal and external GCP and GLP audits of Contract Service Providers, CROs, preclinical and nonclinical CROs and test facilities, laboratories, and supporting vendors.
Conduct study-specific and process audits, reviewing clinical and nonclinical study documentation, data, and records for compliance, data integrity, and adherence to approved protocols, procedures, and applicable regulatory requirements.
Prepare, review, and finalize audit reports; document observations and associated risks; evaluate CAPA 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 provide quality and compliance reporting to support management reviews, inspection readiness, and continuous improvement.
Provide Quality oversight for the development, review, and maintenance of SOPs and quality documents supporting GCP auditing and compliance activities.
Manage the internal GCP audit program, including audit planning, execution, CAPA follow-up, 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, ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements.
Recommend and implement improvements to GCP quality systems, processes, and procedures.
Perform other duties as assigned.