Quality Associate

Our client, a Fortune 500 Pharmaceutical Company, has engaged GForce Life Sciences to provide a Quality Associate to support Global Clinical Quality Management (GQM) activities across multiple clinical studies. This role partners with cross-functional teams to ensure compliance with Good Clinical Practice (GCP), support inspection readiness, manage quality events, and promote continuous quality improvement throughout the clinical trial lifecycle. Requirements Provide Quality oversight for multiple clinical studies from study planning through final reporting. Partner with Clinical Operations, Clinical Managers, Functional Areas, and other cross-functional stakeholders to support study quality activities. Participate in study team meetings and provide quality guidance and best practice recommendations. Support the identification, investigation, and resolution of quality issues, including protocol deviations, data integrity concerns, and potential Serious Breaches. Assist with escalation of significant quality issues to senior management as appropriate. Support risk assessments for the annual GCP audit plan, including identification of site and vendor audit needs. Prepare study documentation and provide support for internal and external GCP audits. Participate in vendor quality risk assessments and support development of the annual Vendor Audit Plan. Review CAPAs, audit findings, inspection responses, and other Quality Management System documentation. Support portfolio-wide inspection readiness activities, including mock inspections, interview preparation, and readiness assessments. Participate in the review and harmonization of controlled documents, including protocols, informed consent forms (ICFs), clinical study reports (CSRs), amendments, templates, and SOPs. Review and support Pharmacovigilance System Master File (PSMF) activities as assigned. Participate in Global Quality meetings and support continuous improvement initiatives. Complete ongoing GCP, ICH, and regulatory training requirements. Qualifications Bachelor's degree in Life Sciences or a related scientific discipline. Experience in the pharmaceutical, biotechnology, or CRO industry supporting Clinical Quality Assurance, GxP Compliance, Clinical Operations, or Regulatory Affairs. Strong knowledge of ICH GCP guidelines, FDA regulations, and global clinical trial requirements. Quality-related training or certifications, including Good Clinical Practice (GCP) and/or Root Cause Analysis (RCA), preferred. Experience supporting GCP inspections, inspection readiness, audit activities, CAPAs, deviations, and Quality Management System (QMS) processes. Strong analytical skills with the ability to identify trends, perform Root Cause Analysis (RCA), and support continuous process improvement. Excellent written, verbal, and interpersonal communication skills with the ability to collaborate across cross-functional teams. Strong organizational skills, attention to detail, and the ability to manage multiple priorities. Experience with TrackWise or another electronic Quality Management System (eQMS) preferred. #J-18808-Ljbffr GForce Life Sciences