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Quality Data and Digital Validation Lead, Loughlinstown
Location: Loughlinstown, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: bebf1b62e19e
Job Views: 9
Posted: 28.04.2025
Expiry Date: 12.06.2025
Job Description:
POSITION SUMMARY
The Quality Digital and Data Validation Lead is responsible for ensuring that Quality Data and Quality Digital Tools are designed, deployed, and maintained globally across the GMS organization to support the product lifecycle. They should be an adept leader with a strong background in electronic system validation, data management, and digital technologies, overseeing electronic computer system validation and driving digital and data solution strategies in partnership with ZTD and cross-functional Zoetis teams.
POSITION RESPONSIBILITIES
1. Validation Strategy and Planning: Develop and execute validation strategies for GMP/GDP relevant electronic systems, focusing on lifecycle management and compliance with regulatory standards such as FDA 21 CFR Part 11 and GAMP 5.
2. Data Solution Development: Collaborate with stakeholders to design and implement digital data solutions, ensuring data integrity, security, and usability, and work with ZTD Program Leads to deploy new functionalities.
3. Validation Documentation and Compliance: Oversee creation and maintenance of validation documents, protocols, and reports, ensuring compliance and providing QA approval on change controls and SOPs.
4. Risk Assessment and Mitigation: Conduct risk assessments for electronic systems, develop mitigation strategies, and influence design and testing decisions to ensure security and privacy.
5. Collaboration and Communication: Partner cross-functionally to align validation activities with business goals, and communicate strategies and outcomes effectively.
6. Data Solution Support: Drive standardization and adoption of core Quality Solutions and support data management practices to ensure data integrity.
7. Continuous Improvement: Lead initiatives to improve validation processes and digital solutions, incorporating emerging technologies and automations, and coordinate audits.
8. Team Leadership and Management: Lead and mentor the validation team and influence senior leadership to adopt systems and data management solutions.
ORGANIZATIONAL RELATIONSHIPS
* Global Quality Function, Site Quality and Operational Teams, Zoetis Technical and Digital Team, GMS Functional Operations, VMRA, Commercial Operations, Legal
RESOURCES MANAGED
* Identify, prioritize, and manage projects within the budget, ensuring timely delivery.
Supervision
* Direct supervision of team members and influence across senior leadership to promote system and data management solutions.
EDUCATION AND EXPERIENCE
* Bachelor’s or Master’s in relevant fields; certifications advantageous.
* 10+ years in FDA-regulated industry, leading qualification efforts for GMP systems.
* Proven experience in electronic system validation, data governance, and digital technologies.
* Strong leadership, communication, and analytical skills.
TECHNICAL SKILLS REQUIREMENTS
* Influence, results orientation, leadership, and change management skills.
* Knowledge of FDA regulations, risk-based validation approaches, and project management.
PHYSICAL POSITION REQUIREMENTS
* Based in Dublin, Ireland or Parsippany, USA; some global travel.
Legal and Benefits Information
Must be eligible to work in Ireland or the USA; benefits include competitive salary, bonus, holidays, pension, private medical insurance, and flexible working options.
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