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Job Title: Audit & Vendor Manager
Role: Manage and execute GCP-focused audits, including internal, investigator site, and external vendor audits, ensuring compliance and quality in clinical development programs.
As a key member of the Clinical Quality Assurance (CQA) team, you will lead planning, execution, and reporting of audits across clinical trials, processes, and vendors. You will oversee clinical vendor qualification and management, collaborate with contract owners, and support regulatory inspections.
Note: This role requires international travel of up to 30%.
Key Responsibilities
1. Lead planning, conduct, and reporting of international GCP audits.
2. Manage audits by third-party vendors, ensuring quality and standards alignment.
3. Maintain and review the risk-based audit plan biannually.
4. Track and report audit metrics and trends.
5. Oversee vendor qualification, onboarding, oversight, and offboarding.
6. Ensure SOPs are current and aligned with best practices.
7. Identify and escalate compliance risks.
8. Contribute to process improvement initiatives.
9. Keep management informed of audit progress and issues.
10. Support inspection readiness and regulatory inspections.
11. Ensure compliance with quality standards, policies, and procedures.
12. Perform other duties as assigned.
Qualifications & Experience
* Degree in a scientific discipline or relevant experience in clinical research or QA.
* Experience conducting international GCP audits or as a regulatory inspector.
* Background in vendor qualification and management.
* Clinical Research or Audit qualification is desirable.
* Experience with GCLP and/or GVP audits is advantageous.
* Proficiency in data analytics is beneficial.
* Excellent communication skills.
* Strong influencing and negotiation skills.
* Deep understanding of GCP and international guidelines.
* Knowledge of other GxPs is a plus.
* Analytical with a risk-based mindset.
* Effective communicator across all levels.
* Collaborative, flexible, and organized.
* Self-motivated and able to prioritize under pressure.
* Decisive and pragmatic in a fast-paced environment.
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