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Data Governance Specialist
3 weeks ago
We are seeking a seasoned leader to spearhead the quality assurance of our cutting-edge biopharmaceutical products. As an Associate Director, you will be responsible for ensuring the highest standards of product quality and compliance with regulatory requirements.
Job DescriptionYou will play a critical role in developing, designing, maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. Your expertise will focus on implementing robust data governance practices, executing computer system validation (CSV), supporting laboratory informatics systems, warehouse and manufacturing systems, and driving compliance with global regulatory expectations.
Key Responsibilities:- Implement Global CS and DI Quality Standards to the new Lilly Limerick site.
- Provide quality direction and governance for QA-owned e-systems, site IT systems, manufacturing systems and site laboratory systems.
- Develop and maintain quality assurance procedures, policies, and systems related to data management, and CSV.
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices), Data Integrity and other relevant regulations.
