Description Overview

*Known internally as Director 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 & 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:

• Bachelor's 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 action management
• Experience recognizing the broad, systemic implications of quality investigations
• Comprehensive understanding of QMS principles and ability to perform as a global head for QMS practices.
• Extensive knowledge of global quality regulations, industry best practices, and international standards and ability to interpret and implement.
• Ability to interface with global health authorities
• Broad expert knowledge of pharmaceutical, medical device, nutritional, API, and cosmetic manufacturing processes.
• Excellent communication skills (verbal, written, and presentation).
• Excellent analytical and problem-solving skills and methodologies.

Skills & Competencies:

• Knowledge, experience, and skills with quality assurance functions. Strong involvement with industry professional associations is preferred. Network within the pharma industry and partner strategically with global regulators.
• Listening, negotiating and effective communication skills under pressure are highly preferred.
• Responsible for daily management of Quality Compliance and Quality Escalations. Develops and implements effective metrics and strategies
• Directs and manages QMS processes and reporting requirements.
• Quality Compliance, Quality Inspection and Audit, QMR, QA, QC, QRM
• Expertise in applying predictive analytics and big data/artificial intelligence to create predictive indicators
• Supports Perrigo Quality Management Review Process