Quality Audits Manager

• 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.

• 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

• 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)

Bayshore HealthCare