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 Area
  
  s, 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 Track Wise or another electronic Quality Management System (eQMS) preferred.