Digital Quality Systems Manager

The Digital Quality Systems Manager is part of the Quality Systems and Standards (QSS) Team reporting to the Quality Digital and Data Lead. This role is the Subject Matter Expert for Quality systems such as SAP QM and Digital QMS, supporting GMS (Global Manufacturing supply) on Manufacting execution systems (MES) global quality alignment and standardizing global processes, translating them into SAP QM, leadind, facilitating workshops, developing & delivering training, protocols and global procedures.in addition, Quality Systems Manager will partner with the impacted Business owners/areas within Quality to ensure technology solutions are developed, validated and implemented to meet requirements and should have a strong background The successful candidate will be a career-driven professional with a strong sense of ownership and a proactive mindset. They will demonstrate exceptional problem-solving abilities and critical thinking skills, enabling them to navigate complex challenges and drive continuous improvement across quality systems and implementation new processes. **POSITION RESPONSIBILITIES**Lead Validation Efforts: Oversee the validation processes for global electronic quality systems, ensuring all systems meet quality standards and regulatory requirements. The role will influence senior leadership across a broad group to train, use, and incorporate certain system changes to insure compliance activities.**EDUCATION AND EXPERIENCE** Significant Operations and/or Quality experience in Animal Health/Human Health manufacturingPrevious Quality Leadership experience Experience managing Global Processes and Operating in a Cross-Functional environmentTechnical Expertise: In-depth knowledge of validation processes, including computer system validation (CSV), and familiarity with relevant tools and software.**TECHNICAL SKILLS REQUIREMENTS** Thorough knowledge of FDA and EU regulations, Good Manufacturing Practices (GMPs), and Good Laboratory Practices (GLPs) requirements impacting manufacturing operationsAdvanced Technical knowledge and/or expertise in Computer System Validation including Electronic Records and Electronic Signatures.Experience with configuration of SAP in Quality Management (QM) and global deployments of ERP within the Pharmaceutical IndustryAbility to work with multicultural, cross-functional work teams and independently – setting clear direction and aligning team and others around common objectivesDemonstrated Strong leadership Skills & broad experience that may include multifunctional, multi-site or other functional experienceDemonstrated success in a Quality Operations/Compliance Role and who can Proactively propose solutions to improve the support of new and existing business processes and demonstrates a strong commitment to product quality, customer service, and continuous improvement.Ability to analyze data and synthesize to make data driven decisions. Ability to Develop and implement initiatives. Broad knowledge of Quality Systems and Risk Management Project Management skills **PHYSICAL POSITION REQUIREMENTS** At , our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
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