Stacey (Whitaker) Basham Email & Phone Number

North Chicago, Illinois, Us

North Chicago, Illinois, Us

North Chicago, Illinois, Us

Lead program managers per assigned therapeutic areas in the development and execution of comprehensive quality assurance plans.Provide strategic planning to ensure resources are available to support plans.Lead development and implementation of cross-functional, continuous quality improvement initiatives.Provide consultation and direction on complex quality assurance and GCP compliance questions from supported organizations.Establish a network across AbbVie functions contributing to clinical development and support cross-functional interactions and learning.Execute AbbVie quality system processes including CAPA, issue escalation, change management, documentation, and personnel qualification.Remain up-to-date on current health authority expectations and incorporate into quality assurance deliverables.Own assigned quality assurance processes (process owner).Provide quality professional development of staff.Lead or co-lead internal and external audits.

North Chicago, Illinois, Us

North Chicago, Illinois, Us

o Interface with Management and consultants on managed programso Conduct audit activities as required, inclusive of process audits and internal assessments (e.g. Quality Plan reviews)o Inform Management of audit/inspection risks based on outcomes of Quality Plan reviews, process audits, sponsor audit findings, regulatory inspection observations, and other quantified outcomes (e.g., oversight activities or compliance metrics)o Serve as Quality Assurance point of contact for clients for all GCP and Inspection Readiness activities

Served as liaison for all GCP and Inspection Readiness activities.Performed internal quality reviews.Conducted external audits, e.g. vendors, investigative sites.Provided guidance on corrective and preventative actions.

Provided Clinical Quality Assurance (CQA) consulting services including auditing, Standard Operating Procedure (SOP) review and development, and on-site training. Served as liaison for all GCP and Inspection Readiness activities.Established project organization as regional member of clinical and quality teams.

Provided direction and leadership to the organizational structure, responsibilities, procedures, processes and human resources for a privately owned international CROMaintained corporate SOPs as well as developed SOPs for clientsOversight of employee training, including maintenance of training recordsAssisted in design and review of essential documents including protocols and Investigator’s BrochuresDirected and lead audits of clinical study sites and vendors Directed and lead audits of TMFs, data listings, reports, tables, and figures Responsible for hosting Regulatory Authority and Sponsor Client audits

Maintained corporate SOPs as well as developed SOPs for clientsOversight of employee training, including maintenance of training records Assisted in design and review of essential documents including protocols and Investigator’s BrochuresDirected and lead audits of clinical study sites and vendors Directed and lead audits of TMFs, data listings, reports, tables, and figuresResponsible for hosting Regulatory Authority and Sponsor Client audits

Ness Ziona, Il

Developed and updated corporate PV procedures and training programReceived and reviewed SAE/SUSAR reports Liaised with Medical Director Prepared patient narrativesAssisted in preparation of PSURDeveloped and updated corporate SOPsAudited clinical sites for quality assuranceWorked directly with the QP for EU batch release productsConducted site selection, budget preparation, collection and review of regulatory documents and pre-study initiation, monitoring and close out visits for the international pilot and Phase I/II/III clinical studiesManaged activities of various CROsAssisted in the development of protocols, CRFs and study related documentsTrained new team members

Ness Ziona, Il

Conducted site selection, budget preparation, collection and review of regulatory documents and pre-study, initiation, monitoring and close out visits for international and pilot Phase I/II/III clinical studiesAssisted in the development of protocols, CRFs and study related documents

Ba, Health Care Studies

Diploma, Nursing