Principal GCP Compliance Specialist (3 month contract) - Oncology Biotech - Greater Boston, MA

Job Reference: #38647 Add to saved jobs

  • Location Greater Boston, MA
  • Contract
  • Sector Pharmaceuticals

Job Summary

The opportunity for a Principal compliance specialist has arisen to join this growing oncology Biotech in Greater Boston. - Travel will be up to 20% max - Strong GCP experience is essential - Extensive auditing experience is also preferred but not essential

Job Overview

- Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols, ICFs.

- Conduct/Lead Internal System, process and documentation 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

- Assist in the management and closure of GCP CAPAs, including metrics tracking and reporting.

- Participate in QA Review of Internal SOPs, driving toward establishing and maintaining harmonized and cross-functional SOPs.

- Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.)

- 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.

Skills Required

- Experience in a Pharmaceutical/Biotechnology Clinical QA role with clinical QA auditing and remediation 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.

- Computer proficiency with Word, Excel, and PowerPoint. Experience with an eQMS (Veeva, TrackWise, Master Control, etc.) is a plus

Contact Details

If you'd like to see the full job description for this opening, please contact or call 646-810-6066.

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