Global GMP Quality Auditor

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 .

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.

DesirableRequirements

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 teams representatives of the patients and communities we serve.