Position: Principal GCP Auditor
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Sr GCP Auditor/Principal will be a critical team member who contributes to implementation of risk-based GCP audit programs and compliance oversight. This person will be responsible for the planning, coordination, execution, reporting and closure across the GCP Auditing spectrum (Site Audit, Vendor Audit, Internal System and documentation Audits, IST audits, and Regulatory Submission Review. The incumbent is responsible for supporting the GCP auditing plan and assisting its management.
- Lead domestic and international Investigative Site Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs.
- Conduct qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, Phase I Units, Imaging Vendors, eTMF Vendors, Investigator Sponsored Trials
- Conduct Internal System and documentation Audits
- Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols, ICFs.
- Assist in the management of the GCP audit program by maintaining audit logs, generating metric reporting, creating templates and others as needed.
- Assist in the management and closure of GCP CAPAs.
- Assist in the management of contract auditors.
- Participate in QA Review of Internal SOPs.
- Perform training and education internally in global GCP standards.
- Represent GCP QA in assigned weekly protocol project team meetings.
- Assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses.
- Support Clinical QA projects.
- Minimum 5 years of increasing experience in a Pharmaceutical/Biotechnology Clinical QA role with at least 3 years of clinical QA auditing experience.
- Strong knowledge of global GCP regulations, guidance, and standards.
- Experience with supporting Health Authority Inspections (FDA, EMA, etc.)
- Must be able to travel in the US and internationally 50%, or as required based on needs.
- Excellent collaboration and partnering skills.
- Ability to work independently and as part of a team.
- Excellent verbal and written communication skills.
- Demonstrated ability to effectively organize and execute tasks in a timely manner.
- Computer proficiency with Word, Excel, and PowerPoint. Experience with an eQMS (Veeva, TrackWise, Master Control, etc.) is a plus
- Experience with the Audit and Review of Safety and Clinical documents is a strong plus
- Ability to work in a fast-paced, highly collaborative, and dynamic environment.
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