TrialSpark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
The GCP Auditor serves as an in-house expert on audit-related matters, maintaining an up-to-date awareness of internal programs and external trends. The GCP Auditor will perform a broad range of audit-related duties (e.g., planning audits, performing audits, ensuring follow-up on findings, providing formal reports, and collaborating with colleagues as needed across various clinical development functional areas such as Data Management, Clinical Project Management, Supplier Management and Oversight etc).
The GCP Auditor may be involved in risk planning for the audit/inspection program. This role leads audits of all types (vendor qualification, internal process, mock audits/inspections) and participates in audits/inspections of all types. The GCP Auditor provides consultation and advice and is involved in the training and mentoring staff. This role may lead development of processes, procedures, tools and training materials.
This role reports into TrialSpark's Head of Quality Assurance.
Duties include but are not limited to:
- Contributing to the development of the company annual GxP audit plan.
- Planning and conducting GCP audits in the Drug Development/Clinical Development realm. Audits may include vendor qualification, sponsor, process, computer system qualification, quality assurance/quality management and investigator site.
- Reporting Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.
- Assisting with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required.
- Writing confirmation letters, and audit plans, agendas, reports and other required audit documentation.
- Providing GCP and inspectional preparedness training to internal team, vendors, and sponsors as required.
- Support regulatory agency inspections and lead the audit and inspection readiness program across the organization.
- Serves as primary liaison with Regulatory Affairs Dept in maintaining an awareness of ongoing regulatory changes
- Bachelor's Degree (or higher) in a life sciences discipline or related field
- 5 years of experience doing GxP auditing within the Pharma/CRO industry
- Ideally 3+ years conducting GCP auditors of clinical investigators, vendors, systems or documents
- A minimum 2 years experience in SOP development and GxP training
- Comprehensive knowledge of regulatory requirements in the responsible area of auditing (GCP, PV, Computer System Validation, etc.).
- Comprehensive understanding of ICH Guidelines [i.e., ICH E6 (R1) and ICH E6 (R2)], appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.
- You're able to thrive in autonomy and work well with cross functional groups
- Experience with software tools used in clinical development
- This position may require minimally 40% travel for conducting audits across the TrialSpark network and vendors.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.