GCP Compliance Head (Technology)

This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. “Please note that this role would not provide relocation and only local candidates will be considered.” The GCP Compliance Head (Technology) is accountable to ensure compliance against GCP for emerging technology and change of strategy in current GCO managed technology, including the use of artificial intelligence (AI) and machine learning in GCO operated clinical trials, and guarantee regulatory adherence in the use of computerized systems and in the collection of electronic data.#LI-OnsiteKey Responsibilities: • Accountability to ensure compliance against GCP for emerging technology and change of strategy in current GCO managed technology, including the use of AI and machine learning in GCO operated clinical trials, and guarantee regulatory adherence in the use of computerized systems and in the collection of electronic data.• Build strong GCP Compliance support with expert knowledge in GxP relevant Enterprise IT systems including validation, user management, security, and electronic data for the data life cycle.• Provide data analytics support to GCP Compliance enabling timely and robust GCP Compliance delivery.• Contributor to the GCO self-assessment strategy development if relevant per scope.• Bring and build GxP expertise in computerized systems in GCP Compliance and GCO.• Contribute to the development of the GCO GCP Compliance vision under the leadership of the Head GCP Compliance, as member of the GCP Compliance Leadership Team, and ensure execution of the vision.• Ensure compliance against GCP for emerging technology and change of strategy in current GCO managed technology, including the use of AI and machine learning in GCO operatedclinical trials, and guarantee regulatory adherence in the use of computerized systems and inthe collection of electronic data, working closely with the relevant functions within GCO, Development and the wider organization.• Build strong GCP Compliance support with expert knowledge in GxP relevant Enterprise IT systems including validation, user management, security, and electronic data for the data life cycle. • Provide data analytics support to GCP Compliance enabling timely and robust GCP Compliance delivery, in collaboration with Strategy Business Insights and Technology (SIT) in GCO and DDIT. · • Provide expert input supporting the GCP Compliance Community in all GCP Compliance pillars. · • Contribute to and execute the GCO self-assessment strategy development if in scope, as member of the GCP Compliance Leadership Team and ensure its delivery. Advise by using data mining and assessing relevant indicators/ metrics/thresholds on the selection of robust checks and controls and support the development of standardized methodologies, tools and repository. ·
• Monitor relevant indicators/ metrics/thresholds ensuring the detection of unreported issues, trends and early signals of risks associated with the use of GxP relevant computerized systems landscape including the use of AI and machine learning in GCO operated clinical trials.