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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:
86
Posted:
21.01.2025
Expiry Date:
07.03.2025
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. The Leader reports to the Quality Systems and Standards and Regulatory Compliance Lead and should have a strong background in electronic system validation, data management, and digital technologies.
POSITION RESPONSIBILITIES
* Validation Strategy and Planning: Develop and execute validation strategies and plans for GMP/GDP relevant electronic computer systems and digital solutions, ensuring compliance with regulatory requirements.
* Data Solution Development: Collaborate with Quality stakeholders and business partners to conceptualize, design, and implement digital data solutions aligned with business objectives.
* Validation Documentation and Compliance: Oversee the creation and maintenance of validation documentation, protocols, and reports, ensuring compliance with regulations.
* Risk Assessment and Mitigation: Conduct risk assessments for electronic systems and digital solutions, developing strategies to ensure system reliability and compliance.
* Collaboration and Communication: Partner cross-functionally within GMS to align validation activities with business goals.
* Data Solution Support: Drive standardization and adoption of core Quality Solutions.
* Continuous Improvement: Drive initiatives within the validation process and digital solutions to enhance compliance and efficiency.
* Team Leadership and Management: Provide guidance and mentorship to ensure effective leadership of validation activities.
EDUCATION AND EXPERIENCE
* Bachelor’s or Master’s degree in Computer Science, Information Technology, Data Science, or a related field.
* Minimum of 10+ years of experience in FDA-regulated industry in a Quality Assurance or Computer Systems Validations role.
* Significant experience in electronic computer system validation and digital solution leadership roles.
* Excellent leadership, team management, and communication skills.
PHYSICAL POSITION REQUIREMENTS
* Dublin, Ireland based position (preferred) or Parsippany, USA
* Travel: Some limited global travel as needed
Legal statement
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.
Summary of our Benefits
In addition to being part of the world leading animal health company, 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, and private medical insurance for you and your family.
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