Digital Quality Systems Manager

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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 Manufacturing execution systems (MES) global quality alignment and standardizing global processes, translating them into SAP QM, leading, facilitating workshops, developing & delivering training, protocols and global procedures.

Act as the primary quality lead contact for SAP CoE, support & making global quality decisions, managing, authorizing process changes, and managing other digital systems in support of the Quality System Digital and Data Lead. They will direct quality assurance for Zoetis products, identify and resolve SAP QM related process issues, and represent plants to the SAP QM team during escalations.

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 in digital QMS, data management, data integrity and a deep understanding of digital technologies in order to oversee electronic computer system validation and drive digital quality and data solution strategies in partnership with Quality Leadership and Zoetis Tech and Digital (ZTD) Team.

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 implement new processes.

POSITION RESPONSIBILITIES

• Act as the Subject Matter Expert (SME) for SAP QM S4HANA and Digital QMS and Lead the implementation and optimization of Quality Systems e.g SAP QM processes, MES, digital QMS e.g. Veeva Vault
• Support Incidents resolution, new demand fulfilment and end user engagement in the area of SAP QM and its integration with other SAP modules as well as QM interfaces with third party applications (e.g. ETS, LC interfaces).
• Develop end to end business process for GMS to ensure getting products to market (domestic/global) by integrating with inbound and outbound supply chain activity including Supply Chain Quality and In Market Quality
• Represent the quality function in GMS projects related to MES.
• Responsible for QM master data and applying data integrity control in the system configuration.
• Support the SAP Community of Practice to support information sharing, change management and best practice development
• Develop and implement a streamlined process for obtaining approvals and validating enhancement requests.
• Provide input to Learning Development Modules for SAP and act as a Trainer and SME during the NextGen project.
• Lead and support project initiatives to expand and standardize the usage of the SAP solution to improve processes at manufacturing sites, and across the supply chain network.
• Lead Validation Efforts: Oversee the validation processes for global electronic quality systems, ensuring all systems meet quality standards and regulatory requirements.
• Direct Leadership and represent the Digital and data team on global quality projects.
• Support implementation and quality decision maker for non Quality Led system implementations e.g. Manufacturing execution System (MES), Digital and Data projects
• Continuous Improvement: Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality systems and digital solutions validation processes.

ORGANIZATIONAL RELATIONSHIPS

• Global QSS team, Other Center Quality and Operations Functions (i.e.: Quality Operations and Quality platform Leaders, Supply Chain Quality, External manufacturing Quality, Global Supplier Quality and Compliance Auditing (GSQCA), Site Quality
• Veterinary Medicine Regulatory Affairs (VMRA)
• Commercial Operations: Commercial Quality and In-Country Regulatory Managers (ICRAM)
• Manufacturing ZTD and Digital and Data Analytics teams
• Legal

RESOURCES MANAGED

N/A

Supervision

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

• Science or Engineering Bachelors / Master's Degree
• Significant Operations and/or Quality experience in Animal Health/Human Health manufacturing
• Previous Quality Leadership experience
• Experience managing Global Processes and Operating in a Cross-Functional environment
• Fluency with ICH Q10 Preferred
• Technical 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 operations
• Advanced 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 Industry
• A strong communicator who can Influence without Authority; Effectively partner & Gaining alignment in a collaborative environment
• Ability to work with multicultural, cross-functional work teams and independently - setting clear direction and aligning team and others around common objectives
• Demonstrated Strong leadership Skills & broad experience that may include multifunctional, multi-site or other functional experience
• Demonstrated 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.
• Change Agent: Passion to win and can be successful in managing a changing environment
• Ability to analyze data and synthesize to make data driven decisions.
• Ability to Develop and implement initiatives.
• Business Acumen
• Process Owner Management
• Continuous Improvement and break-thru thinking
• Broad knowledge of Quality Systems and Risk Management

PHYSICAL POSITION REQUIREMENTS

Dublin-IRL preferred.

Travel: 5-10%

Position requires flexible work hours, to accommodate varying teams and markets\' time zones.

This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sites.

ACRONYM DEFINITIONS

• QSS: Quality Systems and Standards
• QA: Quality Assurance
• QC: Quality Control
• GMS: Global Manufacturing and Supply
• VMRD/VMRA: Veterinary Medicine Research & Development/ Regulatory Affairs
• MES - Manufacturing Execution System

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