Senior GCP Compliance Auditor - South San Francisco, CA | Biospace
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Senior GCP Compliance Auditor

AbbVie Stemcentrx

South San Francisco, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Key Responsiblities Include:

  • Executing AbbVie quality system processes including those for CAPA, issue escalation, change management, documentation, and personnel qualification within the Early Phase Oncology Development environment..

  • Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures.

  • Conduct audits of investigative clinical sites to assess compliance with regulations, guidelines, policies, procedures and sponsor requirements.

  • Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate.

  • Lead Global Process and System Audits to evaluate Abbott Affiliate offices for compliance to applicable SOPs and local regulations.

  • Review clinical research documents, such as research reports, to assess the quality and compliance to policies, procedures, and applicable governmental regulations.

  • Assist and/or lead in periodic audits to evaluate Vendor R&D facilities, equipment, personnel, methods, practices computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally.

  • Evaluate the potential risk of compliance deficiencies.

  • Review policies and procedures and suggest improvements.

  • Maintain effective communication of project related information.

  • Create quality/compliance training programs for the GPRD organization.

  • Provide consultation and direction on complex quality assurance and GCP compliance questions from supported organizationstraining and consulting services to the organization on GCP compliance issues.

  • Initiate, manage, and/or participate in quality improvement projects.

  • Mentor, coach and train QA auditing staff.

  • Prepare and present multiple project progress reports to update management and keep the team(s) informed.

  • Assist in external audits by regulatory agencies or customers.

  • Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines.

  • Lead Quality team members for project specific activities as required.



Minimum Education Requirements:

  • Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience required.

  • Minimum Experience Required:•5-7 years of Pharmaceutical Industry Experience in Quality Assurance / Regulatory Affairs.
    •5-7 years Clinical Research Development
    •2-4 years QA Auditing Experience (GCP Auditing preferred)

Minimum of 7 years total combined experience required. (Not necessarily the sum of the above)