Clinical Quality and GCP Complaince

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 Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. 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