Ana Carolina Guillaumon Balbo Email & Phone Number

Princeton, Nj, Us

Cambridge, Cambridgeshire, Gb

Mainz, Rhineland-Palatinate, De

Responsible for the Quality Management System (QMS) Framework for GCP, GCLP and GVP. Full development of a robust and comprehensive framework for Inspection Readiness, Preparation and Management, including processes, tools, templates, trackers, trainings and dashboards.Implementation of Veeva eQMS and process owner for Document Management System and Training Management modules.QA lead for Regulatory Intelligence process.

Lawrence Township, Nj, Us

Responsible for the strategy, preparation and management of major Health Authority (HA) GCP inspections across the R&D portfolio, including but not limited to inspections performed by FDA, EMA, MHRA. AIFA, TGA, etc.Responsible for leading (i.e. primary point of contact) GCP Sponsor-Monitor inspections and key Investigator Site inspections, coordinating CAPA plans and keeping oversight of HA commitments in the clinical space. Implementation of risk assessments to define and oversee inspection strategy and to guide resourcing & efforts.Preparation of global clinical teams from the sponsor and high-risk investigator sites for Health Authority inspections, e.g., training, mock inspections and/or mock interviews, pre-inspection visits, risk identification and mitigation.Responsible for maintaining the inspection database updated and for post-inspection commitment/activities.

Lawrence Township, Nj, Us

Implementation of Quality Risk Management framework in the Research & Development organization for Organizational, Processes and Clinical Program levels. Development of processes, procedural documents and tools. Responsible for leading cross-functional teams for risk identification, assessment, management, and monitoring, at organizational, processes and program levels.Design and execution of global Quality Improvement Initiatives (QIIs) for high-risk processes and areas with recurrent major GCP findings, leading cross-functional teams globally and achieving significant process improvements.Development of risk-based methodology for the global GCP Audit Strategy. Creation and maintenance of risk-based Annual Audit Schedules for clinical programs.GCP quality advisor for Quality Management System, Clinical & Regulatory teams. Full support in the management of critical Health Authority inspections globally e.g., Sponsor-Monitor inspections, Pre-Approval Inspections.

Lawrence Township, Nj, Us

Global compliance coordination and GCP advisor for the Nivolumab oncology program. Implementation of Risk assessments to identify high risks and drive GCP audit planning. Planning and execution of various GCP audits such as Investigator Site (phase 1 to 4 clinical trials), Process, System, Protocol level, Country, Clinical Trial Units, Pharmacovigilance, Non-Interventional Research, Investigator-Sponsored Research and Vendor audits. Significant global process improvements resulted from audits.Management of HA inspections globally, e.g., FDA, EMA, ANMAT, INVIMA, INS, ISP, etc. Coordination of CAPA plans from audits and inspections.

Lawrence Township, Nj, Us

Planning and execution of various GCP audits such as Investigator Site clinical trials, Process, System, Country, Pharmacovigilance, Non-Interventional Research and Vendor audits.Management of global HA inspections, e.g., FDA, EMA, ANMAT, INVIMA, INS, ISP, etc. Coordination of CAPA plans from audits and inspections.

Lawrence Township, Nj, Us

Planning and execution of various GCP audits. Management of regional HA inspections, e.g., FDA, EMA, ANMAT, INVIMA, INS, ISP, etc. Coordination of CAPA plans from audits and inspections.

Lawrence Township, Nj, Us

Planning and execution of GMP audits. Management of GMP HA inspections (E.g., ANVISA, COVISA). ISO 9000 certification, GMP training, product complaints, investigations, annual product reviews, change control program, and quality advisor for Manufacturing & Support teams.

Wayzata, Minnesota, Us

Supervisor of the Quality Control & Quality Assurance department for the oils & hydrogenated fat manufacturing facility. Planning and execution of the GMP Audit Program, HACCP Program and ISO 9000 certification.

Food & beverage sensorial analysis, quality certification process and quality consultancy.

• Graduate Degree, Pharmacy & Biochemistry

• Bachelor'S Degree, Quality And Productivity