Medical Device Auditor jobs

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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

• Bachelor’s 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.

#LI-JT2

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson,

Our Base Pay Range for this position

$99,100 - $132,100

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