Bridgewater, New Jersey, United States
As a Quality Consultant from Your Encore works as a Sr. Clinical Quality Assurance Project Manager – Oncology. Work with key stakeholders in accordance with the Takeda Quality Management System (QMS). Responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams.
Consultant for GCP Quality Assurance (Sr. level proficiency) Work with key stakeholders to include commercialization partners to develop Gan & Lee Quality Management System (QMS) manual and oversee Inspection Readiness activities, update SOPs review training documentation and quality/compliance across asset teams/projects and accounts.
As a contractor with Kaizen Clinical for the Lilly M&Q Branchburg, NJ Quality office, assigned roll from Quality GCP training manager to provide GAP analysis and business audit of NCO program for regulatory compliance. Audit program - GDP for program documents, periodic SOP development, review of training content for LMS. Conduct CAPA and class for Mock inspection; Available for FDA inspections to provide program details; Audit quality process, records, files reconciliation and due diligence with master file for NCO. Audit GCP site demonstrated skilled leadership in generation of audit report as required and support of CAPA activities of all audits. Produced detailed set of audit tools for general ICH GCP audit (Phase II, IIIB site audit GCP Training); Training of site TPO and vendor on global GXP regulations for inspection readiness.
Manage and generate new development ideas. Deliver ICH GCP training globally.
Phase III study - In house/on site monitor; for six studies involving 13 PIs and staff while working with site monitor and study team to ensure safety and efficacy of clinical drug trial, provide site support with protocol compliance during study, review regulatory documents and post in data bases i.e. eTMF, see list of duties