DIRECTOR, QUALITY & COMPLIANCE - HYBRID

Green Shield Canada

3d•Hybrid

About The Position

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.

Requirements

Undergraduate degree in pharmacy, nursing, health sciences, life sciences, healthcare administration, quality management, business, or a related field.
Professional background in healthcare, pharmacy, patient support program operations, quality, compliance, patient safety, regulatory affairs, or regulated operations.
7+ years of progressive experience in quality, compliance, pharmacy operations, healthcare operations, patient support programs, nursing/infusion operations, specialty pharmacy, regulated distribution, logistics, or a related regulated environment.
Experience with SOP governance, audit readiness, incident management, CAPA, training governance, quality systems, or compliance oversight.
Strong working knowledge of quality management systems, SOP governance, document control, incident reporting, root-cause analysis, CAPA, change control, training governance, audit readiness, and patient-safety frameworks.
Knowledge of regulated healthcare, pharmacy, specialty pharmacy, patient support programs, nursing/infusion, wholesale, logistics, or distribution environments, including the operational realities of frontline teams.
Understanding of applicable regulatory, professional, contractual, manufacturer, pharmacovigilance, AE/PQC, privacy-related, accreditation, and internal governance requirements, including OCP and Health Canada expectations where applicable.
Knowledge of LMS administration, role-based training programs, training records, competency documentation, SOP acknowledgement processes, and audit evidence requirements.
Build and mature quality, compliance, training, audit-readiness, and patient-safety frameworks across complex operational environments.
Translate regulatory, contractual, quality, and patient-safety requirements into practical standards, SOPs, work instructions, training requirements, and governance processes.
Lead audit preparation, audit response, remediation planning, evidence collection, CAPA tracking, and follow-up to closure.
Develop role-based training frameworks and partner with operational leaders to ensure staff are trained, competent, and working in alignment with approved procedures.
Communicate clearly with executives, operational leaders, frontline teams, auditors, regulators, manufacturers, PSP partners, and cross-functional stakeholders.
Influence leaders and teams without direct authority, using sound judgment, credibility, structure, and practical problem-solving.
Building structure in areas where processes, documentation, training, or accountability are fragmented or immature.
Balancing compliance expectations with operational practicality in a fast-paced, multi-site healthcare environment.
Identifying risk, prioritizing gaps, escalating issues appropriately, and driving sustainable remediation.
Creating a culture of quality, documentation discipline, audit readiness, patient safety, and accountability.
Maintaining independence and quality discipline while partnering constructively with operational leaders.

Nice To Haves

Graduate degree in healthcare administration, business, quality management, regulatory affairs, patient safety, or a related discipline.
Licensed pharmacist, nurse, or other regulated healthcare professional.
Quality, patient safety, risk, regulatory, privacy, project management, Lean/Six Sigma, audit, or change management certification.
10+ years of progressive experience in a regulated healthcare, specialty pharmacy, PSP, pharmaceutical, wholesale, distribution, or infusion clinic environment.
Experience with Health Canada, DEL, OCP, manufacturer audits, PV/AE/PQC obligations, PSP audits, pharmacy accreditation, and multi-site healthcare operations.
Prior people leadership experience preferred.

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.