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Senior Auditor, Clinical Quality and Compliance
2 months ago
As a Senior Auditor, Clinical Quality and Compliance, you will play a key role in ensuring the quality and compliance of our clinical studies. Your expertise will be essential in maintaining our high standards and ensuring that our clients receive the best possible service.
Responsibilities- Develop and implement robust audit plans to ensure compliance with regulatory requirements
- Conduct audits of clinical sites, studies, and vendors to ensure quality and compliance
- Provide guidance and support to auditors and other team members on audit techniques and risk assessment
- Review and assess non-compliance issues and develop corrective action plans
- Collaborate with the Quality Systems group to ensure that all audits are conducted in accordance with our quality management system
- Develop and deliver training content on quality and compliance topics
- 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 skills 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 is a contract research organization (CRO) specializing in dermatology. We are committed to providing high-quality research and services to our clients, and we are looking for talented individuals to join our team.
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.