Director of Global Quality Management Systems

Job description

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Director of Global Quality Management Systems

Location:

Dublin, IE, D02 TY74

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, ACO, 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 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 for directing, consulting, developing, implementing, maintaining, and ensuring 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 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.
  
  
• Participate 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 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.
  
  
• Analyse audit non-conformances and implement comprehensive & systemic corrective and preventive action plans.
  
  
• Track and trend Quality Indicators.
  
  
• Review Corporate Quality audit reports and prepare 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.
  
  
• 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.
  
  

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.

Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration.

But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

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

Find out more here .

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.

(The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

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.

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Required Skill Profession

Quality Management & Operations