Sr. Specialist, Clinical Quality Assurance
3 months ago
- 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.
- 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.
- 25%-30% travel may be required
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