Director, Quality & Compliance - Hybrid

The Director, Compliance, Quality & Patient Safety is responsible for leading the quality, compliance, audit-readiness, and patient-safety framework across GreenShield Pharmacy’s integrated operations, including specialty pharmacy, digital pharmacy, patient support programs, nursing and infusion clinics, wholesale (DEL), logistics, and distribution.

The role owns the development and maturity of the Quality Management System, SOP governance, incident reporting, root-cause analysis, CAPA, training governance, audit management, pharmacovigilance oversight, and quality reporting. This role ensures operational practices are compliant, documented, scalable, and aligned with applicable regulatory, contractual, manufacturer, accreditation, privacy-related, and internal governance requirements.

The outcome of this role is a more mature, consistent, and audit-ready quality infrastructure that supports patient safety, reduces organizational risk, strengthens partner and regulator confidence, and enables sustainable operational growth.

Key Responsibilities

• Own and mature the Quality Management System across pharmacy, patient programs, nursing/infusion, wholesale, logistics, and distribution, ensuring quality standards are translated into practical day-to-day operating procedures.
• Provide governance over SOPs, policies, work instructions, operational workflows, document control, versioning, review cycles, approvals, change management, archiving, and audit retrieval.
• Lead the training governance framework, including LMS oversight, role-based training requirements, training records, SOP acknowledgements, and learning documentation to ensure teams are trained, compliant, and operating consistently.
• Lead the organization’s audit-readiness framework and support internal audits, external audits, inspections, accreditation activities, and partner reviews.
• Ensure operational practices align with applicable OCP, Health Canada, DEL/wholesale, manufacturer, PSP, pharmacovigilance, AE/PQC, privacy-related, contractual, and internal governance requirements.
• Coordinate audit responses, remediation plans, evidence packages, reconciliation requirements, quality checks, and follow-up actions through to closure.
• Lead the framework for identifying, reporting, investigating, escalating, and trending quality events, operational incidents, patient-safety concerns, service failures, cold-chain issues, documentation gaps, privacy-related operational deviations, and compliance issues.
• Ensure root-cause analysis, corrective and preventive actions (CAPA), effectiveness checks, and trend reviews are consistently completed and documented.
• Drive a culture of transparency, learning, accountability, patient safety, and continuous improvement.
• Own the training governance framework for pharmacy, nursing/infusion, patient programs, One Point case management, customer service, pharmacy assistants, logistics, wholesale, and related operational roles.
• Define role-based training requirements, onboarding standards, SOP training, competency expectations, LMS documentation, training records, retraining requirements, and evidence of completion for audit purposes.
• Partner with operational leaders to ensure teams are trained to perform their roles consistently, safely, and in alignment with approved procedures, without owning day-to-day operational performance or CI delivery.
• Develop quality reporting and key quality indicators to provide visibility into compliance posture, audit readiness, patient-safety trends, CAPA status, training compliance, PV/AE/PQC compliance, and emerging risks.
• Establish and lead cross-functional quality governance, including a Quality and Patient Safety Council, to review trends, escalate risks, and drive accountability for remediation.
• Partner with operations, clinical, technology, privacy, legal, risk, finance, people, and external stakeholders to embed quality expectations into daily operations and transformation initiatives.