Director of Global Quality Management Systems
Ireland 8 hours ago
Job Description
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(R), Compeed(R), Solpadeine(R), NiQuitin(R), ACO(R), 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 a blended:branded business to win in self:care.
Description Overview
*Known internally asDirector of Global Quality Management Quality Systems: Deviations, CAPA, Change Control, and OOS*
The Director of Global Quality Management Quality Systems: Deviations, CAPA, Change Control, and OOS is responsible to direct, consult, develop, implement, maintain, and ensure that these quality system elements are maintained effectively. In this role, you will develop and implement strategies to ensure compliance with regulatory standards, manage global quality deviations and CAPAs, oversee global quality change control processes, and govern global lab investigations to maintain product quality and safety. You will be a subject matter expert providing guidance for all global corrective and preventive action matters. You will engage effectively with all global Perrigo sites, affiliates and with global health authorities to identify mechanisms to assure that our practices, policies, and quality system elements meet current regulatory expectations. You will participate and support the escalation of quality investigations and change events to executive leadership through appropriate tiered governing processes where appropriate.
Scope of the Role
:Optimise, further develop and implement improvements in the global quality management systems, including deviations, CAPA, change control, and lab investigations, policies and quality standards.
:Collaborate with cross:functional teams to implement quality compliant corrective and preventive actions (CAPAs). Optimise CAPA processes in Perrigo
:Participates in trade and/or professional organizations to ensure that state:of:the:art industry standards / changes are incorporated into Global strategy,
:Optimise and oversee change control processes
:Direct the global change control review board for Perrigo
:Optimise and drive the deviations and CAPAs processes to identify root causes and implement corrective actions.
:Monitor and review QA and QC data to identify trends and identify areas for improvement.
:Optimise and drive the lab investigations process to ensure the highest quality standards of investigations
:Optimise documentation practices and processes related to quality investigations
:Analyses audit non:conformances and implements comprehensive and systemic corrective and preventive action plans.
:Tracks and trends Quality Indicators.
:Reviews Corporate Quality audit reports and prepares appropriate corrective action responses.
:Provide training and support to employees on quality management systems and procedures.
:Ensure stakeholder management is optimized for QMS elements
Experience Required
Qualifications:
:Bachelors degree in: Pharmacy, Chemistry, Biology, Engineering or a related field.
:Minimum of 10 years of experience in quality systems, quality assurance, quality control, or risk management within the pharmaceutical industry or equivalent
:Significant knowledge of systems and processes which support Quality Management System. Specifically, operational experience in the core QMS processes such as quality change control, deviation handling, quality control, and corrective and preventive ac
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