Compliance Auditor II

The Compliance Auditor II is a key member of the Corporate Quality Compliance Team, responsible for ensuring adherence to cGMPs and applicable regulatory standards (including those set by Health Canada, FDA, EU, and other international bodies).

The position involves conducting internal and supplier audits, maintaining audit programs, and collaborating with cross-functional teams to enhance compliance across the organization.

Key Responsibilities

Audit Execution & Oversight

• Develop, maintain, and implement the Internal and Supplier Audit Program in line with current GXP (GMP, GLP, GDP) standards.
• Plan and execute audits with a systematic approach, including scheduling, defining scope, and resource allocation.
• Issue detailed audit observations and reports with minimal need for revision.
• Review and assess responses and CAPAs from audits and conduct follow-up to ensure implementation and effectiveness.
• Conduct for-cause audits addressing suspected critical findings, fraud, or misconduct.
  
  

• Support regulatory inspection preparedness and act as a co-host during audits.
• Assist site operations and perform follow-up activities post-inspection.
• Report audit metrics to relevant stakeholders at the site, departmental, and corporate levels.
• Participate in quality events such as Change Controls, CAPAs, and Deviations.
• Lead or contribute to cross-functional projects aimed at improving compliance and supplier qualification processes.
• Review and approve specifications and SAP source lists related to components and materials.
• Represent Quality Assurance in projects involving new suppliers or materials.
  
  

• Bachelor’s degree in a relevant scientific, technical, or life sciences field; equivalent experience may be considered.
• Minimum five (5) years of related experience, including at least two (2) years in a pharmaceutical or FDA-regulated environment.
• Demonstrated experience in aseptic pharmaceutical manufacturing is preferred.
• Strong understanding of quality systems and proficiency in conducting both supplier and internal audits.
• Familiarity with regulatory inspections and requirements from Health Canada, FDA, EU, and ISO standards.
• Skilled in identifying compliance gaps and recommending practical solutions.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint); working knowledge of SAP and TrackWise preferred.
• Ability to travel up to 10%-40% as required.
  
  

If you would like to learn more about this great opportunity, please email and reference job# 19356