Senior Corporate Compliance Auditor

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Job Summary

The Senior Corporate Compliance Auditor Supplier & Risk provides pharmaceutical compliance oversight for audit activities supplier qualification risk management and inspection readiness across McKesson

Canada businesses.

This role requires strong warehousing distribution 3-PL compliance expertise and the ability to interpret and navigate Health Canada expectations and applicable GXPs Controlled Substances Medical Devices and corporate quality requirements into practical audit criteria supplier controls CAPA expectations on a risk-based approach.

The position acts as a compliance subject matter expert for internal supplier transporter client and regulatory audit activities ensuring that audit records supplier files quality agreements deviations CAPAs KPIs and compliance trends are complete accurate defensible and inspection-ready. The role also requires strong proficiency with digital technologies data analytics and AI-enabled tools to support compliance activities and continuous improvement.

The Senior Corporate Compliance Auditor will perform the following activities:

Compliance Oversight & Audit Execution

• Plan lead and execute internal (including but not limited to distribution center Private Label 3-P PV clinics) supplier transporter client and regulatory-readiness audits including compliance assessment evidence review reporting observation classification and CAPA follow-up in accordance with pharmaceutical regulatory and corporate requirements.

• Assess compliance with applicable regulations according to the specific activities performed or service provided.

• Ensure audit records are evidence-based risk-classified complete and inspection-ready.

• Perform or oversee periodic risk assessments related to audit outcomes supplier performance quality events CAPA effectiveness and emerging compliance risks.

• Analyze audit findings deviations supplier issues and CAPA data to identify trends systemic occurrences repeat observations and opportunities to strengthen the quality systems.

• Maintain dashboards KPIs and compliance metrics for audit execution supplier performance CAPA effectiveness overdue actions and inspection readiness; provide risk-based recommendations to leadership.

• Create or revise SOPs work instructions templates audit tools checklists and training materials to strengthen compliance controls and standardize practices.

• Provide practical compliance guidance and training on audit expectations supplier oversight documentation standards CAPA quality and inspection readiness.

• Effectively use and optimize digital quality tools including audit/supplier systems (Master Control) dashboards to improve compliance visibility traceability and efficiency.

• Recommend and implement digital compliance tools for efficacy and continuous improvement

Supplier Compliance & Qualification

• Execute and maintain supplier lifecycle controls including qualification requalification risk classification monitoring performance review and periodic compliance assessment.

• Ensure supplier files are complete current and inspection-ready including approvals audit reports CAPAs and performance records.

• Evaluate supplier compliance risks related to regulated activities outsourced services transporters storage distribution and quality-critical products or services.

• Support audit frequency decisions using supplier risk performance history regulatory impact audit outcomes quality events and business criticality.

• Track follow up and escalate supplier non-conformances quality commitments overdue actions and recurring compliance issues.

• Work with the business to establish strategies with the at risk or non compliant suppliers.

Collaboration Decision-Making & Scope

• Collaborate with cross-functional stakeholders to ensure supplier onboarding qualification and ongoing oversight are compliance-driven and risk-based.

• Make recommendations within established frameworks escalating supplier non compliances based on patient/product impact regulatory exposure business risk and compliance significance.

• Influence quality and compliance decisions through regulatory expertise digital tools analytics audit insights and ownership of assigned program elements.

Experience & Qualifications

• Bachelors degree in Science Pharmacy Engineering Quality Regulatory Affairs or a related field.

• 7 years of experience in pharmaceutical Quality compliance auditing supplier quality regulatory compliance distribution manufacturing or a related regulated environment.

• Strong pharmaceutical compliance background is required including practical experience applying GMP/GDP and Health Canada expectations in audit supplier oversight CAPA and quality system activities

• Strong experience in warehousing 3-PL and QA distribution

• Demonstrated expertise in interpreting and applying Health Canada regulations GxP requirements and corporate quality system standards across diverse regulated product categories including pharmaceuticals narcotics precursors natural health products food controlled substances and medical devices.

• Experience conducting and/or hosting internal supplier transporter client or regulatory audits including audit response writing and CAPA follow-up.

• Experience managing supplier qualification quality agreements risk classification performance monitoring and inspection-ready supplier documentation.

• Knowledge of Good Pharmacovigilance Practice and pharmacovigilance regulations is considered an asset; manufacturing auditor certification or formal audit training is also considered an asset.

• Up to 30-50% travel required to Canadian locations and international sites; valid passport required.

• Hybrid position able to comute to our McKesson site in Milton Ontario and GTA.

Skills

• Strong ability to apply regulatory and quality requirements proportionately adapting audit scope evidence expectations and compliance controls based on business activities licence requirements product types operational complexity and risk profile.

• Strong analytical skills including compliance trending KPI review risk analysis and CAPA effectiveness assessment.

• Excellent documentation and technical writing skills for evidence-based inspection-ready audit records and compliance reports.

• Strong judgment attention to detail communication in English and French stakeholder engagement and ability to manage multiple audits and priorities in a regulated environment.

• Ability to lead continuous improvement activities through structured problem-solving engagement of others and sustained compliance focus.

• Strong verbal and written communication skills in English required; French language skills are an asset.

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Our Base Pay Range for this position

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