Senior Auditor, Clinical Quality and Compliance

4 weeks ago

Montreal, Quebec, Canada Innovaderm Research Full time
Job Title: Senior Auditor, Clinical Quality and Compliance

Join our team of experts at Innovaderm Research as a Senior Auditor, Clinical Quality and Compliance. In this role, you will be responsible for leading the establishment of audit plans, assessing and ensuring compliance in study conduct, and providing strong support to operations via GxP consultation.

About the Role

This is a challenging and rewarding role that requires a strong understanding of norms and regulations, combined with a creative and inquisitive mind. As a Senior Auditor, Clinical Quality and Compliance, you will be part of a small team that contributes to the success of our organization.

Responsibilities
  • Implement robust audit plans and execute audits in accordance with the established audit program.
  • Act as a lead/mentor for the conduct of audit activities (site, studies, internal and vendors). Performs review of audit reports issued by the auditors.
  • Coordinate and conduct clinical sites audits with the project management team. Where applicable, facilitate the audit with external auditors.
  • Participate in the auditor's training in providing guidance on audit techniques, risk assessment, and system approach.
  • Formulate observations/recommendations and review the appropriateness of audit responses/CAPA plan and track progress.
  • Review and assess non-compliances, adequacy of CAPA plan, and track the progress of action items. Lead thorough and complete investigations where needed.
  • Provide solid recommendations/guidance via GxP consultation and support auditors in their consultation as needed.
  • Organize and host sponsor's study audits and regulatory inspections, including mock inspection activities.
  • Work closely with the Quality Systems group for internal, vendor audits, and periodic risk review of vendors. Can also be involved in client's qualification audits and review of SOPs.
  • Develop training content for topics related to SOPs, regulations, and GxP. Can provide training to Innovaderm employees.
  • Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified, and/or have received adequate training.
About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology with a team of over 350 employees. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America.

We are committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

We thank you for your application and please note that only those selected for an interview will be contacted. Innovaderm only accepts applicants with a work permit for Canada.

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