Quality Audits Manager

Job Summary

Reporting to the National Director of Scientific Affairs, Quality, Ethics and Compliance, the Manager, Quality Audits will serve as the subject matter expert in planning, leading, and conducting audits and self-inspections. This role is pivotal in fostering an industry-leading compliance culture within the organization. The Manager will collaborate with internal and external cross-functional stakeholders and act as a Quality Audit SME for GxP systems and ISO compliance.

Duties and Responsibilities

• Execute the self-inspection framework in alignment with the Audit RACI, formulating a risk-based internal self-inspection plan.
• Plan, lead, and conduct internal self-inspections, including risk-based audits.
• Own and maintain self-inspection SOPs and associated audit checklists.
• Provide oversight, coordination, and audit readiness support for external Pharma audits and regulatory inspections.
• Assess the need for, and assist in the development of, robust and achievable CAPA plans; approve and monitor CAPA timelines.
• Lead and support external audit/inspection and self-inspection readiness activities:
• Deliver “Audit Dos and Don’ts” training to prepare internal teams.
• Proactively identify and manage compliance risks to minimize audit observations.
• Maintain up-to-date audit/inspection readiness checklists and documentation repositories.
• Coordinate the full audit lifecycle: scheduling, documentation requests, training, logistics, follow-up, and CAPA tracking.
• Maintain accurate documentation of auditing activities, including audit matrices and observation trends.
• Develop and present Quality Audit Metrics and KPIs to the leadership team.
• Educate internal teams on quality events, root cause analysis, investigations, and effective CAPA writing.
• Collaborate with Quality Event owners to ensure proper documentation, RCA, and implementation of effective CAPAs.
• Lead completion of compliance-related questionnaires (e.g., Pre-Audit Surveys, Vendor Qualification, Security Risk Assessments).
• Identify and communicate potential compliance vulnerabilities to leadership.
• Support updates to the BSRx Quality Manual and ensure audit readiness.
• Monitor ISO and Health Canada regulatory requirements and adapt internal processes accordingly.
• Lead and support GxP and ISO alignment across applicable business lines.
• Use technical and business writing skills to communicate process changes effectively.
• Provide proactive quality and compliance guidance to internal stakeholders.
• Build strong rapport with stakeholders at all levels.
• Mentor Quality colleagues and support their professional development.
• Perform other quality and compliance-related duties as assigned.
  

Qualifications

• Graduate or professional degree in a scientific or health administration discipline, or an equivalent combination of education and experience.
• Minimum of five (5) years of relevant experience, including at least three (3) years in a leadership role directly supporting GMP and GVP audits.
• ASQ Certified Quality Auditor (CQA) and/or ISO Quality Auditor certification (or other relevant quality certification) is required.
• Lean Six Sigma Certification is a plus.
• Pharmacovigilance Certification is a plus.
• Experience in a healthcare environment is a plus.
• Bilingual (French/English) is a plus.
• In-depth understanding of GxP regulations, including:
• Good Manufacturing Practices (GMP)
• Good Clinical Practices (GCP)
• Good Pharmacovigilance Practices (GVP)
• Good Documentation Practices (GDP)
• ASQ Quality guidelines
• ISO 9001 requirements and standards
  

Additional Skills

• Experience working in a Pharmaceutical GMP environment is desired.
• Experience auditing third-party vendors, including 3PL (third-party logistics) activities.
• Strong business writing skills.
• Experience in incident management and investigations.
• Proficient in technical writing, including policies, SOPs, work instructions, and CAPA documentation.
• Experienced in internal and external Pharma audits, Health Canada inspections, and ISO audits.
• Familiarity with Quality Systems, including but not limited to:
• Document Management Systems (DMS)
• Change Control
• Quality Management Systems (QMS)
• Learning Management Systems (LMS)
  

Primary Location

ON-Markham