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