Associate Manager, Quality Assurance – Operations

Responsibilities

• Quality Event Management (Incidents / Deviations / Investigations): Lead intake, triage, and tracking of quality events (incidents and deviations), ensuring accurate classification, risk assessment, escalation, and on-time initiation of investigations.
• CAPA Management (Corrective and Preventive Actions): Own CAPA governance from initiation through closure: ensure appropriate linkage to incidents/deviations/audit findings/complaints, clear problem definition, risk-based prioritization, and compliant documentation.
• Change Control Management: Lead the change control process for operational, procedural, system, supplier, and material changes: ensure changes are appropriately documented, risk assessed, and reviewed/approved by required stakeholders.
• Data Insights, Metrics, and Continuous Improvement: Own QA Operations performance reporting (KPIs/KRIs) including event volume and aging, investigation and CAPA cycle time, effectiveness, recurrence, and change control throughput; ensure data quality and consistent definitions.
• Maintain inspection/audit readiness for QA Operations processes by ensuring procedures, training, and records support consistent execution.

Requirements

• Education: Bachelor’s degree in life sciences, pharmacy, nursing, health administration, quality, or a related discipline (or equivalent combination of education and experience).
• Experience: 5+ years of progressive quality experience in a regulated healthcare environment (PSP, clinical services, specialty pharmacy, distribution/logistics, or GxP) with demonstrated ownership of investigations/deviations/incidents, CAPA, and change control; prior people leadership or strong experience leading teams/cross-functional initiatives preferred.
• Skills: Strong working knowledge of investigation practices, CAPA governance, and change control; effective root cause analysis and risk-based decision making; excellent documentation and stakeholder communication; strong organization and ability to manage priorities/aging items; ability to translate metrics and trending into actionable insights; demonstrated coaching/people leadership capability.
• Experience with structured problem-solving and continuous improvement methodologies (e.g., DMAIC, Lean, A3, 8D) is an asset.
• English proficiency is required for this position to effectively communicate with internal and external stakeholders. Bilingualism (French and English) may be required depending on the specific role, location, and the needs of the organization.