Senior Auditor, Clinical Quality and compliance/ Sr Auditeur, qualité clinique et conformité Canada

Job Overview The role of the Sr. Auditor, Clinical Quality and Compliance is to act as lead person in establishing audit plans, assessing and securing compliance in study conduct and to provide strong support to operations via GxP consultation. 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) and review audit reports issued by auditors. Coordinate and conduct clinical site audits with the project management team; facilitate audits with external auditors as applicable. Participate in auditor training and provide guidance on audit techniques, risk assessment and system approach. Formulate observations/recommendations and review appropriateness of audit responses/CAPA plan and track progress. Review and assess non‑compliances, adequacy of CAPA plan, and lead thorough investigations where needed. Provide solid recommendations/guidance via GxP consultation and support auditors as needed. Organize and host sponsor study audits and regulatory inspections, including mock inspections. Work closely with the Quality Systems group for internal, vendor audits and periodic risk review of vendors; may also be involved in client qualification audits and SOP reviews. Develop training content for SOPs, regulations and GxP; provide training to employees. May be assigned to other responsibilities that do not pertain to their former description if qualified. Qualifications Bachelor’s degree in a relevant discipline or equivalent experience. 5–10 years of experience in the pharmaceutical or research industry, specifically in clinical quality. Knowledge and Skills Excellent knowledge of ICH guidelines, FDA and Health Canada regulations, and EU standards. Master the overall audit process and risk determination. Ability to communicate effectively both orally and in writing. Good organizational skills and ability to adapt to a rapidly growing environment. Bilingual: French and English (written and spoken). Good knowledge of Microsoft Office Suite (Word, Excel, PowerPoint). Willing to travel 10–30% of the time. Work Environment At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment, and teamwork. We offer a stimulating work environment and attractive advancement opportunities. Benefits Flexible work schedule Permanent full‑time position Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) Offices near public transportation (Sherbrooke metro or Saint‑Laurent metro station) Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology with a team of over 350 employees. Since 2000, Indero has built a solid reputation for quality research and services. Based in Montreal, Indero continues to grow in North America and Europe. EEO Statement Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants with a work permit for Canada. Recruiting Information We’re unlocking community knowledge in a new way. Experts add insights directly into each article, starting with the help of AI. Seniority level Not Applicable Employment type Full‑time Job function Quality Assurance Industries Research Services #J-18808-Ljbffr