Job description

What You'll Do:

Conduct Vendor Audits, Internal System Audits and Investigator Site Audits
Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits, Clinical Database Audits, Investigator Site Audits, etc. on an ad hoc or scheduled basis as determined by the Sponsor and CTI management
Prepare audit plans for audits and projects and programs, as needed
Clearly communicate and report (verbally and in writing) audit outcomes and escalate significant compliance concerns to project teams, QA and CTI management and sponsor contacts appropriately
Identify and follow up on any unresolved audit observations identified in a Quality Assurance Audit
Host Sponsor audits of CTI. Assure that issues from Sponsor audits are promptly communicated to the appropriate team members, assist with the development of a corrective action plan and facilitate the resolution of all audit findings
Complete Sponsor audit/qualification questionnaires
Report, manage, and follow quality events (deviations), complaints, issues, non-compliances, and their related Corrective and Preventive Actions (CAPAs)
Assist with quality assurance training for junior CTI QA staff
Prepare training materials and conduct training related to relevant QA topics for CTI staff
Assist with creation, review, revision and management of SOPs
Host Regulatory Authority inspections of CTI. Assist the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections
Assist with completion of request for information (RFI) business proposals related to Quality Management Systems
International region-specific functions
Act independently in providing quality assurance-related solutions to both internal and external customers

What You'll Bring:

5-8 years of progressive experience in clinical (GCP) Quality Assurance or relevant pharmaceutical and/or CRO experience in Quality Assurance
Bachelor’s Degree or equivalent combination of education and experience

Why CTI?

Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process

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