IT Technical Regulatory Compliance Principal - REMOTE

Jobgether

2d•Remote

About The Position

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.

Requirements

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.

Responsibilities

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.