Job Description
Job Summary: Ensure IT systems, programs, and quality events meet regulatory expectations. Liaise with IT and QA organizations to ensure compliance and internal policies are met.
Responsibilities:
• Manage compliance monitoring of operations and evaluate effectiveness of corrective actions
• Investigate and troubleshoot problems, determine solutions or recommendations for changes and/or improvements
• Review and approve deviation notifications, investigations, and corrective actions
• Participate in Quality Risk Management (QRM) initiatives and review Quality Assurance Agreements (QAA)
• Present at internal and external audits and support quality objectives
• Stay up-to-date with industry trends and regulatory requirements and drive changes and improvements based on trends
Requirements:
• In-depth knowledge of 21CFR11, Annex 11, MHRA, FDA, and WHO data integrity guidelines
• Strong knowledge of Computer Systems Validation and/or IT Auditing
• Ability to define a vision and implement interim milestones
• Strong knowledge of applicable federal, state, and local regulations, rules, policies, and procedures
• Ability to capture relevant facts, assess, and decide to execute
Education and Experience:
• BA/BS degree required
• Minimum of 5 years directly related experience within Pharma or Biotech or equivalent combination of education and experience
Regeneron's Culture:
• Inclusive and diverse culture
• Comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off
• Equal opportunity employer, committed to diversity and inclusion