Senior Quality Assurance Specialist

This position is onsite located in Los Angeles, CA

The Senior Specialist, Clinical Quality ensures GCP compliance with standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times.

Essential Functions

• Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
• Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
• Ensures compliance with SOPs and ICH GCP E6 (R2) standards.
• Manages the incident management program through monitoring of complaints, deviations and CAPAs.
• Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
• Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans
• Validates accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
• Reviews the final audit documents for accuracy.
• Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs
• Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies.
• Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
• Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
• Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable.
• Lead development and implementation efforts for inspection readiness at all times.
• Assists senior staff during regulatory inspections or other audits.
• Represents QA department at internal and external meetings supporting clinical programs.
• Performs other Quality related duties, as assigned.

Education & Experience

• Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master’s degree in a life sciences or engineering discipline with a minimum of 4 years’ of experience in a GCP-Biologics or Pharmaceutical environment.
• CQA or other audit certifications are a plus.
• Prior TMF or electronic document management systems experience is a plus.
• Demonstrated understanding and application of ICH GCP E6 (R2)12
• 25%-30% travel may be required