Clinical Quality & GCP Compliance Lead

Perrigo; Allegan Township (MI); On-site; USD 100,000 - 150,000; Full time

Job summary

Perrigo is seeking a Clinical Quality Assurance Professional to provide independent QA oversight of GCP and GLP activities across Perrigo’s global development portfolio. The role leads audits, supports inspection readiness, and serves as a subject matter expert on GCP compliance and regulatory requirements.

The successful candidate will manage CSP/CRO audits, CRO quality agreements, and CAPA processes while ensuring data integrity and adherence to FDA, ICH, and EU guidelines.

Qualifications

• Certification in SQA or lead auditing is required.
• Experience conducting global audits across US, EU, UK, Japan, and other regions.
• Experience with eCOA, computerized system validation (CSV) and data management.

Responsibilities

• Plan, conduct, and manage internal and external GCP/GLP audits of CSPs, CROs, labs and vendors to ensure regulatory compliance.
• Review study documents, data, and records for adherence to protocols and regulatory requirements.
• Prepare audit reports, document observations, and track CAPA closures with effectiveness verification.
• Develop and maintain GCP quality agreements with CROs and partners.
• Maintain GCP audit metrics and deliver reports for inspections and quality improvements.
• Oversee SOPs and quality documents supporting GCP auditing and compliance.
• Support mock inspections, regulatory inspections, and responses.

Skills

SQA Certification

Lead Auditor

Global Audits

eCOA

CSV

Data Management

Tools

eCOA systems

CSV tools

Clinical data management systems

Job description

Perrigo is seeking a Clinical Quality Assurance Professional to provide independent QA oversight of GCP and GLP activities across Perrigo’s global development portfolio. The role leads audits, supports inspection readiness, and serves as a subject matter expert on GCP compliance and regulatory requirements.

The successful candidate will manage CSP/CRO audits, CRO quality agreements, and CAPA processes while ensuring data integrity and adherence to FDA, ICH, and EU guidelines.