Global GMP Quality Auditor

Novartis; Montreal (administrative region); On-site; CAD 120,000 - 180,000; Full time

Job summary

Novartis Canada is seeking a senior QA/audit professional to plan, lead and execute GMP audits across global operations and external partners. You will assess regulatory compliance, quality systems, and CAPA effectiveness, while documenting findings and guiding improvement.

The role requires expert communication in English, a willingness to travel ~60% worldwide, and the ability to train teams and provide strategic guidance on regulatory expectations in a fast-paced pharmaceutical environment.

Qualifications

• Degree in Chemistry, Pharmacy, Biology, Engineering, or related discipline.
• Minimum 10 years in pharma/medical device QA/QC management and manufacturing.
• Experience interacting with regulatory health authorities.
• Excellent knowledge of regulatory requirements and English communication.

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.

Skills

GMP audits

Regulatory knowledge

Stakeholder management

English proficiency

Travel readiness

Education

Chemistry

Pharmacy

Biology

Engineering

Related discipline

Job description

Summary

Location: Remote/Canada or Remote/Mexico. For the role posting in Mexico, please see REQ-10086366. Novartis will not offer relocation support for this role.

About The Role

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.
• Excellent oral and written English communication skills.

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.

At Novartis Canada, we are determined to be a valued partner and advocate, with a deep understanding of patient needs along the entire care journey – from drug development, to diagnosis, to access and beyond. Part of the way we are doing this is by leveraging data, technology, and partnerships.

Research & Development

we focus on four core therapeutic areas: Cardiovascular, Renal & Metabolic, Immunology, Neuroscience and Oncology. We also develop and deliver treatments through other promoted and established brands, which today are helping millions of patients. Over the last three years, our average annual research and development investment in Canada was over $30 million, and we conduct clinical trial research in every region throughout Canada.

Commitment to Diversity and Inclusion

Novartis is committed to building outstanding, inclusive work environment and diverse team’s representatives of the patients and communities we serve.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)