- Validation Strategy and Planning: Develop and execute validation strategies and plans for GMP/GDP relevant electronic computer systems and digital solutions; have major focus on the lifecycle management of all GMP/GDP relevant computerized systems, ensuring compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5) and industry standards.
- Data Solution Development: As the business process owner for Quality Management Systems (e.g. ZLIMS, Veeva Vault, ETS, Empower) and Quality Stakeholder for Enterprise systems (e.g. SAP), collaborate with Quality stakeholders and business partners to conceptualize, design, and implement digital data solutions aligned with business objectives, ensuring data integrity, regulatory compliance, security, and usability. Work closely with ZTD Program Leads in the Lab and Quality Operations capability towers to deploy new functionality and/or systems to address business needs in these capability areas.
- Validation Documentation and Compliance: Assist with the development of system requirements and specifications to ensure requirements that are testable, and that21 CFR Part 11 requirements are met as applicable. Oversee the creation and maintenance of validation documentation, protocols, and reports, ensuring accurate and compliant records of validation activities and system functionalities. Provide QA approval on all GMP functional change controls, validation documents and SOPs. Coach the implementation teams in the proper execution of validation documents. Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans in compliance with regulation and internal Zoetis Quality Standards.
- Risk Assessment and Mitigation: Identify and qualify all computer systems which impact cGMP operations using a risk based methodology. Conduct risk assessments for electronic systems and digital solutions, identifying and escalating potential risks and developing mitigation strategies to ensure system reliability and compliance. Influence design and testing decisions to ensure security and privacy risks are considered and mitigated.
- Collaboration and Communication: Collaborate and partner cross-functionally within GMS and with ZTD Program Leads to align validation activities and digital solutions with business goals. Effectively communicate validation strategies and outcomes across the organization. Liaise with GMS and ZTD teams to harmonize and streamline validation practices across sites
- Data Solution Support: Drive Communities of Practice to ensure standardization and adoption of core Quality Solutions and support sites in Data management practices to assure data integrity.
- Continuous Improvement: Drive continuous improvement initiatives within the validation process and digital and data solutions, incorporating emerging technologies, automation, and best practices to enhance compliance, efficiency and effectiveness. Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses
- Team Leadership and Management: Leads team providing guidance, mentorship, and support to ensure effective ownership and leadership of validation activities and solution implementations.
- Global Quality Function including Quality Systems and Standards, Quality Platform Leads, External Supply Quality , Supply Chain & Logistics Quality Operations (SCL QO) and Global Quality Compliance & Auditing (GQCA)
- Site Quality and Operational Teams
- Zoetis Technical and Digital Team (ZTD) and Data Analytics
- GMS Functional Operations (e.g. GMT including automation and Engineering)
- Veterinary Medicine Regulatory Affairs (VMRA)
- Commercial Operations: Commercial Quality and In-Country Regulatory Managers (ICRAM)
- Legal
- Identifies, costs and prioritises projects for annual Budgeting and ensure on time delivery and execution
- The role will give direct supervision to identified team members
- The role will influence senior leadership and business owners across a broad group as identified above to train, use, and incorporate systems and data management solutions.
- Bachelor's or Master's degree in Computer Science, Information Technology, Data Science, or a related field. Certifications in validation, project management, or relevant technologies are advantageous.
- Minimum of 10+ years of experience in FDA-regulated industry in a Quality Assurance, Compliance or Computer Systems Validations role, leading and managing qualification efforts for GMP relevant applications.
- Significant years of progressive experience in electronic computer system validation, data management, or digital solution leadership roles, with a strong understanding of validation principles, data governance, and digital technologies in a pharmaceutical manufacturing environment
- Proficiency in validation tools, data management platforms, and knowledge of digital solution architectures and methodologies
- Excellent leadership, team management, and communication skills, with the ability to lead, inspire, and collaborate with multidisciplinary teams.
- Strong analytical thinking, problem-solving abilities, attention to detail, and a commitment to maintaining high-quality standards.
- Influence without Authority; Gaining alignment of leadership groups on Key Data and Digital objectives
- Results oriented.
- People Management / Demonstrated Leadership Skills
- Demonstrated success in a Quality Operations Role
- Passion to win and can be successful in managing a changing environment
- Business Acumen
- Continuous Improvement and break-thru thinking
- Experience and knowledge with FDA regulations as they pertain to information and digital solutions, especially 21 CFR Part 11, as well as relevant aspects of corporate privacy requirements.
- Experience with risk-based approach to system validation and testing.
- Experience in the development and execution of computer validation documentation.
- Experience in the development and maintenance of standard operating procedures.
- Experience with managing technology delivery projects, from inception through delivery and post-production support, of manufacturing and quality information and digital solutions (processes and systems) in an FDA-regulated industry.
- Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
- Ability to work independently, and on multiple concurrent project initiatives.
- Enthusiasm to learn and share ideas and solutions effectively with management and colleagues.
- Dublin, Ireland based position (preferred) or Parsippany, USA
- Travel: Some limited global travel as needed Full time
Quality Data and Digital Validation Lead - Loughlinstown, Ireland - Zoetis
1 week ago
Description
POSITION SUMMARY
The Quality Digital and Data Validation Lead is responsible to assure that Quality Data and Quality Digital Tools are designed, deployed, and maintained globally across the GMS organization to support the product lifecycle and that they are aligned, lean and efficient, facilitate ease of use and are compliant with industry regulations and quality standards.
The Leader reports to the Quality Systems and Standards and Regulatory Compliance Lead and should be an adept and forward-thinking leader, with a strong background in electronic system validation, data management, and a deep understanding of digital technologies in order to oversee electronic computer system validation and drive Quality digital and data solution strategies in partnership with ZTD and cross functional Zoetis teams towards delivery of our Ambitious Digital and Data Strategies.
While possessing a strong background in electronic system validation, data management, and a deep understanding of digital technologies and Regulatory expectations for a pharmaceutical manufacturing environment, the leader should be highly motivated by the prospect of being part of a talented, innovative, and collaborative team and show a bias for action, problem solving and operational excellence.
POSITION RESPONSIBILITIES
ORGANIZATIONAL RELATIONSHIPS .
RESOURCES MANAGED
Financial Accountability
Supervision
EDUCATION AND EXPERIENCE
TECHNICAL SKILLS REQUIREMENTS
PHYSICAL POSITION REQUIREMENTS
Legal statement as below
This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.
Visa status re must be eligible to work and live in Ireland as below
Colleague must be legally eligible to live and work in Ireland.
Summary of our Benefits
In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few.