Information Security GxP Specialist - Remote

Overview

In this vital role, you will work closely with various groups to ensure that GxP controls are in place, manage GxP deviations, and ensure security standards are met.

In Short

• Manage and own technology-related GxP deviations and CAPA records.
• Collaborate with record owners and QA for timely record resolution.
• Recommend improvement strategies for GxP deviation management.
• Ensure compliance with industry standards and regulatory requirements.
• Assist in preparation for audits and inspections.
• Support development of IT governance and compliance frameworks.
• Conduct CAPA applicability assessments and identify improvement opportunities.
• Supervise and report on the efficiency of existing GxP records.
• Communicate complex GxP concepts to non-technical collaborators.
• Work effectively with global, virtual teams.

Requirements

• Doctorate degree or 5+ years of experience in IT GxP deviation management.
• Hands-on experience with deviation management tools and frameworks.
• Good understanding of GxP deviation management and IT security standards.
• Excellent problem-solving and analytical skills.
• Familiarity with compliance standards like GDPR and HIPAA.
• Proficiency with GxP management tools and GRC software.
• Strong verbal and written communication skills.
• Ability to manage multiple priorities successfully.

Benefits

• Competitive and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative culture.
• Opportunity to make a lasting impact in biotechnology.