Regeneron-ireland-dac is seeking a Principal GMP Data Governance Specialist to ensure our Data Governance systems and practices adhere to the highest regulatory and industry compliance standards.
Key Responsibilities:
* Evaluate current and emerging regulatory guidance and industry intelligence concerning IOPS business practices
* Author and develop standards, policies, and procedures in compliance with regulatory requirements and industry best practices
* Conduct technical writing, research, and editing activities to ensure documentation accuracy and consistency
* Generate data mapping processes and conduct risk and criticality assessments of all GMP documentation
* Identify potential data governance and integrity gaps, propose solutions, and lead DI remediation activities
* Collaborate with Technical DG Experts, ECM Experts, and DG Business Partners to deliver the DG plan and provide feedback
Requirements:
* Bachelor's degree in a relevant field (e.g., data management, quality assurance, compliance)
* 8+ years of professional experience in pharmaceutical/FDA-regulated environments
* Proven technical writing experience and familiarity with workflows and quality management terminology
* Excellent communication skills and ability to collaborate with cross-functional teams
Culture and Benefits:
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer committed to diversity, equity, and inclusion. We celebrate differences and promote a culture of belonging, respect, and open communication.