Manager, Clinical QA - GCP & Pharmacovigilance Auditing

Shionogi Inc   •  

Florham Park, NJ

Industry: Pharmaceuticals & Biotech


Not Specified years

Posted 72 days ago

This job is no longer available.


  • Audit clinical trials including clinical investigator site audits, clinical vendor audits, directed audits, site preparedness inspections in anticipation of health authority inspections to assess the quality level and compliance with applicable GCP regulations in support of Shionogi clinical programs.
  • Create formal audit reports and identify critical audit findings to senior management, including recommendations for corrective action and/or regulatory reporting, if necessary.
  • Participate in inspection readiness activities to include but not limited to: planning and preparing for health agency inspections, participating in mock/health authority inspections and post inspection activities (e.g. CAPA generation/ CAPA tracking)
  • Conduct and/or assist with internal audits.
  • Conduct due diligence audits/activities.
  • Review and approve audit responses.
  • Ensure effective closure, by working with "auditees" to ensure comprehension, development and execution of corrective/preventive action with regard to any non-conformities cited during audits.
  • Participate in preparing the annual audit schedule and audit plans
  • Participate in the planning, coordination, execution and follow-up activities supporting health agency inspections.
  • Develop/modify audit checklists, SOPs, WI and other GCP QA as regulatory requirements change.
  • Participate in the development of process improvement strategies and tools related to GCP compliance efforts.
  • Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups.
  • Perform/participate in vendor and/or license partner pharmacovigilance (PV) audits. Generate audit reports. Review the adequacy of audit responses. Track/manage on time completion of audit commitments.
  • Participate in the Quality & Compliance Team and Pharmacovigilance System Master File (PSMF) activities/meetings as GCP/PV Quality representative.
  • Approximately 35% participation in pharmacovigilance activities, and will support of other QA projects as needed.
  • Travel – approximately 50% - includes international.


  • BA/BS in the life sciences required.
  • At least 4 years of relevant pharmaceutical industry experience, including a minimum of 2 years of GCP/PV auditing experience.
  • Thorough knowledge of ICH Guidelines, GCPs and pharmacovigilance including regulatory requirements for the conduct of clinical development programs.
  • Excellent oral, written and verbal communication skills.
  • Appropriate technical skills in GCP/PV compliance.
  • Proven interpersonal skills.
  • Familiarity with GLP and database audit practices a plus.
  • Knowledge of international guidelines and audit experience a plus.
  • Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.