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Senior Auditor Clinical Quality and Compliance
2 months ago
Join our team at Innovaderm Research as a Senior Auditor Clinical Quality and Compliance. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical research operations.
Key Responsibilities:- Develop and implement robust audit plans to ensure compliance with regulatory requirements and company policies.
- Conduct audits of clinical sites, studies, and vendors to identify areas for improvement and ensure compliance with regulatory requirements.
- Provide guidance and support to auditors and other team members on audit techniques, risk assessment, and system approach.
- Review and assess non-compliance issues and develop corrective action plans to ensure compliance.
- Collaborate with the quality systems group to ensure that all quality-related activities are aligned with company policies and regulatory requirements.
- Develop and deliver training content on quality-related topics to employees.
- Bachelor's degree in a relevant discipline or equivalent experience.
- 5-10 years of experience in the pharmaceutical or research industry, with a focus on clinical quality.
- Excellent knowledge of ICH guidelines, FDA and Health Canada regulations, and EU standards.
- Ability to communicate effectively both orally and in writing.
- Good organization skill and ability to adapt to a rapidly growing environment.
- Bilingual: French and English, written and spoken.
- Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint).
- Willing to travel 10-30% of the time.
Innovaderm Research is a contract research organization (CRO) specializing in dermatology. We are committed to providing high-quality research services to our clients and are dedicated to ensuring the highest standards of quality and compliance in our operations.
We offer a stimulating work environment, attractive advancement opportunities, and a comprehensive benefits package. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
