Director Global Quality Risk Management

Job title: Director Global Quality Risk Management

Company: Perrigo


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®, 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 OverviewThe Director of Global Quality Risk Management is responsible to direct, consult, develop, implement, maintain, and ensure that the overall cGMP quality risk management program within Perrigo is robust and aligned to ICH Q9 International standards. In this role, you will be involved in developing a Quality risk management programme for Perrigo and then leading, developing and implementing strategies to identify, assess, and mitigate risks to ensure the safety and efficacy of Perrigo products. You will lead evaluation of risk to patient and consumer safety and product quality based on scientific knowledge, data and experience. You will enrich the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks. You will provide global leadership for QRM Risk Planning, Risk Assessment, QRM Tools, Risk Control, and Risk Outcomes through a Quality Risk Register.Scope of the Role

• Develop, implement, and monitor quality risk management programs, policies and processes throughout the product lifecycle
• Leads, defines and implements the application and the complexity of risk management tools needed to be appropriate to the scope of the risk event, the level of risk, the desired output from the risk assessment, and the elements of the QMS under evaluation.
• Implements and manages the company’s overall approach to Risk Management as defined in a formal Risk Management Plan (RMP).
• Implement the Perrigo QRM process, procedures and training, insight into effective facilitation of risk assessments and the QRM toolkits.
• Direct, develop and manage a Quality Risk Management Plan enabled by an understanding and the application of a holistic lifecycle-based QRM process, inclusive of risk ranking, risk decision tree, and risk assessment tools
• Lead specific strategies for defining the criteria for risk ratings and risk mitigation requirements
• Review the importance and necessity of tracking and monitoring the outputs of risk assessments including outputs for trending and process improvement
• Understand how risk assessments align with the overall implementation of a robust QRM system that is applicable for the product lifecycle, including Quality Change Control, Quality Investigations for Deviations and Lab Events, and Consumer Complaints
• Mentor facilitation skills necessary to successfully navigate risk assessment discussions
• Implement human heuristics and organizational culture tools and develop influence risk management programs
• Support and participate in internal and external audits and inspections.
• Maintains an effective liaison and cooperative relationship with Quality, Regulatory, R&D, and Operations partners
• Develops and implements statistical quality programs and process monitoring systems.
• Enable and support the Quality Management System

Experience RequiredQualifications:

• Bachelor’s degree in: Pharmacy, Chemistry, Biology, Chemical Engineering, or a related field.
• Minimum of 10 years of experience in quality risk management, quality assurance, and quality control within the pharmaceutical industry or equivalent
• Strong knowledge of GMP, regulatory requirements, and quality management systems.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal and stakeholder management skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite and quality management software.

Skills:

• Quality Risk Management, Expert in ICH Q9 requirements
• Expert in Quality risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks
• 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 monitoring of development programs for compliance with Perrigo quality standards, regulatory agencies requirements, and global standards/requirements
• Responsible for daily management of Quality Risk Management
• Develops and implements effective metrics and strategies
• QMR, Quality Compliance, Quality Inspection and Audit, QA, QC, Quality Management Review

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 at Perrigo.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 moreApplicants 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. #weareperrigo

Expected salary:

Location: Dublin

Job date: Thu, 06 Mar 2025 23:32:54 GMT

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