IT Technical Regulatory Compliance Principal - REMOTE

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an IT Technical Regulatory Compliance Principal. In this role, you will be pivotal in leading and executing IT risk-based computer systems validation and ensuring technical compliance across critical business sectors such as laboratory services and clinical trials. You will collaborate with various teams to ensure that IT systems comply with industry regulations, guiding the organization through audits and maintaining rigorous documentation standards. Your expertise will drive efficiency and alignment with regulatory requirements, ensuring the integrity and quality of IT operations.

• Lead IT compliance initiatives ensuring adherence to world-wide regulatory authorities, GLP, GCP, and other applicable regulations and standards.
• Manage and execute validation of cloud-based and hosted applications, including risk assessments and validation testing.
• Primary owner of the system development lifecycle and CSV process, ensuring compliance with policies and procedures.
• Oversee the new system implementation process and IT change management process.
• Develop and maintain key compliance and SDLC documents such as validation protocols and test scripts.
• Prepare and lead IT-related activities for regulatory inspections and audits, managing quality events and CAPAs.
• Author IT compliance policies and standard operating procedures to ensure consistent practices across teams.
• Collaborate with IT infrastructure and business system owners to align compliance activities with business needs.
• Enhance IT validation and compliance processes for improved efficiency and support of digital transformation.
• Participate in cross-functional discussions to provide quality guidance and decisions for technical projects.

• Bachelor degree in computer science.
• 10 years experience in life sciences computer systems validation.
• Five years employment in a lab services environment.
• Five years in a biotech, pharma or device environment.
• Detailed knowledge of IT infrastructure and computerized system validation concepts.
• Experience with ISPE GAMP 5 methodology and validation deliverables.
• Strong documentation and technical writing skills.
• Familiarity with ITIL and project management experience.
• Experience with cloud service providers and enterprise applications.
• Exceptional communication and leadership skills.

• Opportunity to work in a fully remote environment.
• Competitive salary range based on experience and qualifications.
• Access to professional development and training opportunities.
• Participation in a collaborative and innovative team culture.
• Comprehensive benefits package including health, dental, and retirement plans.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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