The Senior GCP Compliance and QA Auditor will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, procedures, and appropriate processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors.
Here Is What You Will Be Doing:
- Responsible for assuring the quality of clinical systems, processes, and related activities.
- Ensures programs, including clinical trials, meet global regulatory and Passage Bio requirements.
- Manage and conduct both internal and external quality audits, while supporting a compliance culture and process improvement.
- Act as the liaison for Clinical trial-related activities, including clinical meeting representation and review of clinical procedures and procedural documents.
- Implement and maintain Passage Bio QA audit program to support aspects of pre-clinical to post-approval clinical programs. Lead qualification, routine, and for-cause audits of external service providers, including CROs, investigator sites, laboratory and data management vendors, and other vendors to assess effectiveness of their QMS and compliance to approved study protocols and contracts.
- Conduct internal and external document reviews and audits, including regulatory application documentation, protocols, study reports, and Trial Master File documents.
- Assist with inspection readiness activities for third party audits of Passage Bio and external service providers, including regulatory authority inspections.
- Coordinates tracking of document requests and responses.
Here Is What You Will Bring To The Table:
- Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.).
- Minimum 5 years of GCP auditing experience of Early Phase and Late Phase clinical trials in the CRO and/ or Pharma industries required
- Experience hosting sponsor audits & regulatory inspections highly preferred
- Experience with gene or cell therapy auditing programs
- Experience working with Quality Management Systems
- Knowledge and experience of Part 11 validation requirements and other GxPs (GLP, GVP, GMP, GDP, etc.) preferred
- Ability to execute strategy and plans
- High degree of flexibility and ability to adjust to changing priorities and unforeseen events
- Travel approximately 35% domestically and internationally