Clinical Quality and GCP Complaince

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

Clinical Quality and GCP Complaince

Location: Allegan, MI, US, 49010

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

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.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

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

Nearest Major Market: Grand Rapids

Equal Employment Opportunity/M/F/disability/protected veteran status.
Equal employment opportunity, including veterans and individuals with disabilities.

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