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Job Description Summary
#LI-Remote
Job Description
Key Responsibilities
• Plan, lead, and execute GMP audits across global operations and external partners.
• Assess compliance with regulations, quality standards, procedures, and guidance documents.
• Document audit observations, prepare reports, and communicate findings to stakeholders.
• Review and approve corrective and preventive action plans addressing audit findings.
• Provide expert guidance and training on audit activities.
• Escalate critical compliance issues and support timely mitigation activities when required.
• Maintain expertise in evolving regulations, industry standards, and quality expectations.
Essential Requirements
•Degree in Chemistry, Pharmacy, Biology, Engineering, or another related scientific discipline; other degrees with relevant experience may be considered.
•Minimum 10 years of broad experience in the pharmaceutical or medical device industry, including QA/QC management and manufacturing, development, or other relevant experience such as working at a regulatory health authority.
•Expertise in at least one of the following areas: drug product (DP) manufacturing, biologics, sterile manufacturing, laboratories, microbiology, packaging, active pharmaceutical ingredients (API), excipients, medical devices, computer system validation, or quality systems.
•Excellent knowledge of regulatory requirements, with experience and/or interaction with local Health Authorities and sporadically with other Health Authorities; sound and practical judgement in the interpretation and application of regulations and standards.
•Strong interpersonal skills, including diplomacy, persuasion, and stakeholder management.
•Willingness to travel approximately 60% globally.
•Advanced French and English speaking and writing proficiency.
English language proficiency is required due to the need to participate in national and international meetings conducted in English and review scientific and strategic materials primarily available in English. These responsibilities are an essential part of the role and cannot be performed solely in French.
Desirable Requirements
• 3 years auditing experience
• Proficiency in an additional language such as German, French, Italian, Chinese, or Spanish.
Skills Desired
Collaboration, Data Integrity, Decision Making, Leadership, Risk Management
