Senior Auditor

Under the responsibility of the Compliance Manager, the external auditor is responsible for the complete management of the supplier qualification process for Riva and AVIR PHARMA, from initial qualification to periodic requalification, including planning and conducting external and internal BPF audits, evaluating and supporting the GMP evidence management process according to the requirements of GUI-0080, tracking corrective and preventive action plans, managing quality risks, participating in pre-evaluation activities (due diligence) for new projects, and establishing, reviewing, and maintaining quality agreements. The incumbent contributes actively to ensuring that suppliers, subcontractors, and partners comply with applicable Health Canada, ICH, recognized pharmacopeias, and other relevant regulatory requirements. The position requires excellent organizational skills, effective priority management, and the ability to adjust priorities as needed based on operational needs, quality concerns, or regulatory requirements.

Main Tasks and Responsibilities: External and Internal Audits

• Support the external supplier audit program and the internal audit program as needed and according to established priorities.
• Prepare and maintain the annual schedule for external and internal audits.
• Schedule audits with suppliers.
• Conduct external and internal audits in accordance with current Canadian BPF requirements, internal procedures, and applicable standards.
• Write reports and follow up on responses.
• Supplier Qualification, Requalification, and Monitoring
• Actively participate in the prequalification of new suppliers; provide recommendations on the BPF level of suppliers.
• Manage quality-related risks in accordance with Riva and AVIR Pharma procedures.
• Exercise professional judgment to identify potential issues with certain suppliers and escalate them in a timely manner to the appropriate individuals, when they may impact quality, compliance, timelines, or the continuity of operations.
• Participate, as needed, in due diligence activities for new projects, including the preliminary evaluation of potential suppliers, sites, services, or partners, as well as the identification of quality, regulatory, or GMP risks that may impact the project.
• Support the GMP evidence management process in accordance with the requirements of GUI-0080, including the collection, evaluation, tracking, updating, and archiving of documents required for supplier qualification and maintenance.
• Manage the complete lifecycle of suppliers, including initial qualification, site and service evaluation and approval, continuous performance monitoring, periodic requalification, and management of changes that may have a quality or regulatory impact.
• Monitor actions required following audits, observations, deviations, changes, critical complaints, recalls, or unfavorable regulatory inspection results involving suppliers.
• Quality Agreements and GMP Contractual Obligations
• Establish, negotiate, review, and maintain quality agreements with suppliers, partners, and subcontractors, ensuring they reflect applicable responsibilities, sites, products, services, and regulatory requirements.
• Prepare key performance indicators related to external and internal audits, supplier qualification, quality agreement status, action tracking, and applicable compliance activities.
• Use and maintain relevant information in applicable systems and tools, including SharePoint, Dot Compliance, and Microsoft Office suite, to ensure traceability, document tracking, and effective activity management.
• Manage priorities proactively and demonstrate flexibility when operational needs, timelines, quality urgencies, or regulatory requirements necessitate a change in established priorities.
• Perform any other tasks related to compliance activities.

Skills, Knowledge, and Abilities

• Ability to interpret various regulations related to BPF to implement external and internal audit programs.
• Proficiency in Health Canada BPF requirements and EU standards for all sectors related to medicines, natural health products, and medical devices.
• Ability to communicate effectively to facilitate constructive exchanges with partners and suppliers.
• Organized, structured, and rigorous person with a good analytical mindset, excellent observational skills, and the ability to manage multiple cases with varying priority levels.
• Professional judgment and the ability to recognize situations requiring escalation, particularly when a supplier issue presents a potential risk to compliance, product quality, timelines, or regulatory commitments.
• Ability to write clear, concise, and appropriate technical reports for audit reports, risk assessments, quality agreements, regulatory follow-ups, and communications with suppliers.
• Key Requirements and Competencies:
• Bachelor's degree or master's degree in sciences, with at least 5 years of experience in the pharmaceutical domain. Experience in external and internal audits is an asset.
• In-depth knowledge of Canadian BPF, ICH standards, and USP, EP, and BP pharmacopeias.
• Proficiency in the various regulatory requirements related to the different business sectors of Riva-Trianon and AVIR Pharma (DIN, NPN, narcotics, sterile products).
• Experience with various dosage forms and product categories, including natural health products, medical devices, injectable sterile products, ophthalmic products, creams, liquids, tablets, capsules, and other relevant pharmaceutical forms.
• Ability to work in a dynamic environment where priorities can change quickly, while maintaining a high level of quality, tracking, and compliance.
• Proficiency in English, both oral and written.
• Knowledge of remote communication tools and the ability to collaborate effectively with suppliers, partners, and colleagues located in different countries or time zones.
• Structured, organized, and detail-oriented person.
• Proficiency in computer and document management tools used in a quality environment, including SharePoint, Dot Compliance, and Microsoft Office suite.
• This position requires travel, including some trips outside the country, for conducting external audits and visits to suppliers.
• Salary: $65,205.55 to $106,213.97 per year

Benefits

• Dental Insurance
• Disability Insurance
• Vision Insurance
• Contribution equal to the RÉER
• Company Events
• On-site Gym
• Flexible Start and End Times
• Employee Assistance Program
• On-site Parking
• Location: On-site