Global GMP Quality Auditor

🔥 0 minutes ago

🌐 Canada, Mexico – Remote

🇨🇦 Canada – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🔎 Auditor

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Novartis

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Novartis is an innovative medicines company dedicated to reimagining medicine to improve and extend people’s lives. With a presence in over 250 million patients worldwide, Novartis focuses on harnessing scientific breakthroughs to develop transformative, high-value treatments in areas such as cardiovascular, renal and metabolic diseases, immunology, neuroscience, and oncology. The company is committed to diversity, equity, and inclusion, and aims to create a positive impact through societal contributions and environmental sustainability efforts. Furthermore, Novartis engages in research collaborations and embraces modern technology platforms to advance their research and development capabilities, making them a leader in the global healthcare industry.

📋 Description

• 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 • Maintain expertise in evolving regulations, industry standards, and quality expectations

🎯 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 relevant regulatory health authority experience • Expertise in at least one area: drug product manufacturing, biologics, sterile manufacturing, laboratories, microbiology, packaging, active pharmaceutical ingredients, excipients, medical devices, computer system validation, or quality systems • Excellent knowledge of regulatory requirements and experience with local and other Health Authorities • Sound and practical judgment in interpreting and applying 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 proficiency required for national and international meetings and reviewing scientific and strategic materials • 3 years auditing experience preferred • Proficiency in an additional language such as German, French, Italian, Chinese, or Spanish is desirable

🏖️ Benefits

• No relocation support offered • Commitment to diversity and inclusion • Global healthcare organization environment • Opportunity to work with diverse manufacturing sites, development centers, contract manufacturers, laboratories, warehouses, and suppliers • Opportunity to influence positive change in healthcare