Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: The Senior IT Operations Risk Analyst is responsible for creating, monitoring, and improving Governance in relation to Patch Management and Risk processes and procedures for GMP Client operating systems, Laboratory and Automation workstations, Anti-virus, as well as hardware monitoring tools.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Works and assists with various IO Teams as a client governance expert on projects and offers council regarding the intent of GMP client requirements.
• Assists in handling Discovery/Gap Analysis initiatives and coordinates with various functional groups to resolve noncompliance status for assigned clients.
• Assists during audits to manage the process of providing all requested evidence of our standards of client implementations.
• Works with IO and global security team members leadership to ensure security best practices are identified and integrated into all facets of projects including client designs/configuration, and implementations.
• Assists in documenting standards, processes, and procedures for incident response, security systems, and tools as needed.
• Creates, reviews and updates architectural and configuration documentation.
• Software patching and vulnerability remediation - maintains client management tool for patching. Researches, runs, and audits application, workstation, and complete patching on a quarterly basis
• Assists in monitoring and supports security software/systems that will help ensure compliance with regulatory, industry, and corporate policies and procedures. This includes but is not limited to: endpoint security (McAfee and Carbon Black) Application Whitelisting/Blacklisting, Data Integrity monitoring tools and be the Owner of the Group Policy objects for GMP Client systems.
• Mitigates key risks by identifying and recommending changes to policies and procedures.
• Supports various operations technologies, including vulnerability scanning, multi-factor authentication systems, provides risk guidance for IT projects and recommendations for controls relating to third party management.
• Isolates and resolves incident tickets related to GMP client systems.
• Identifies areas where existing group policy architecture requires improvement and develops proposals, processes and implementation plans.
• Provides technical and operational support to various business units including Labs and Automation.
Knowledge and Skills:
• Knowledge of 21 CFR Part 11, Annex 11 Regulations and Good Manufacturing Practice (GMP)
• Ability to work with multiple teams and partners to handle vulnerabilities and fix issues efficiently
• Must show strong judgment and time management skills
• Ability to communicate at all levels with clarity and precision both written and verbally
• Excellent interpersonal skills with strong customer service focus
• Ability to maintain integrity and honesty at all times
• Continuously drive to improve processes for improved performance
• May manage others through influence rather than direct authority
• Handle issues appropriately and with a sense of urgency
• Identify and effectively communicate risks
• Ability to problem solve and identify root cause
Education and Experience:
• Requires BS/BA in related field; may substitute relevant industry experience for educational requirement
• 5+ years relevant experience in a GxP environment required
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.