Associate Manager, Quality Assurance; Operations

Position: Associate Manager, Quality Assurance (Operations)
Associate Manager, Quality Assurance (Operations)
Are you ready to make a lasting impact in specialty care? BioScript Solutions is seeking a dedicated and dynamic Associate Manager, Quality Assurance (Operations) to join our team where patients are always our top priority.

What we offer

Epic Work-Life Balance: flexible remote work options to value your time and well‑being.

Growth Opportunities: a culture of growth where every team member is encouraged to develop new skills, expand knowledge, and advance careers.

Vibrant Culture: over 1,500 team members across Canada and strong engagement reflected in quarterly pulse surveys.

Attractive Compensation: competitive salary, incentive program, and comprehensive benefits package.

Remote & Full‑Time, Permanent

Closing Date:
June 24, 2026

Quality Event Management (Incidents / Deviations / Investigations)

Lead intake, triage, and tracking of quality events, ensuring accurate classification, risk assessment, escalation, and prompt initiation of investigations.

Ensure investigations meet consistent standards (problem statement, containment/corrections, root‑cause analysis, risk evaluation, documentation) and partner with Operations, Clinical, Pharmacy, and IT as needed.

Maintain audit‑ready records that meet data‑integrity expectations with clear, objective writing and traceable evidence.

Escalate quality risks, overdue events, or recurring issues and facilitate cross‑functional problem solving for timely containment and sustainable resolution.

CAPA Management (Corrective and Preventive Actions)

Own CAPA governance from initiation through closure, ensuring linkage to incidents, deviations, audit findings, or complaints, clear problem definition, risk‑based prioritization, and compliant documentation.

Coach teams on root‑cause analysis and robust action plans; challenge weak fixes and ensure owners, milestones, and due dates are defined and met.

Plan and execute CAPA effectiveness checks; verify sustained implementation and measurable risk reduction; raise issues when actions are ineffective or trends persist.

Change Control Management

Lead the change‑control process for operational, procedural, system, supplier, and material changes with proper documentation, risk assessment, and stakeholder approvals.

Ensure impact assessments address patient safety, regulatory requirements, data integrity, and business continuity; confirm completion of implementation activities such as training, document updates, and validation where applicable.

Drive timely closure through change‑effectiveness reviews, maintain an audit‑ready repository, and communicate change status and key risks to management.

Data Insights, Metrics, and Continuous Improvement

Own QA operations performance reporting (KPIs/KRIs) including event volume, aging, investigation and CAPA cycle times, effectiveness, recurrence, and change‑control throughput; ensure data quality and consistent definitions.

Perform trend analysis to identify recurring issues and systemic risks; translate insights into targeted improvements and present recommendations to leadership.

Apply structured improvement methods (Lean, DMAIC) to reduce investigation/CAPA cycle time, improve documentation, and decrease recurrence of high‑risk issues.

Maintain inspection/audit readiness for QA operations processes by ensuring procedures, training, and records support consistent execution.

Stakeholder & Client Partnering (Quality Governance)

Provide QA operations governance support to internal stakeholders and clients/sponsors: respond to quality inquiries, support issue communications, and align on expectations for investigation/CAPA/change‑control deliverables.

Coordinate quality commitments and reporting (action logs, metrics packages, periodic quality reviews) and ensure timely delivery and closure of agreed‑upon actions.

Audit & Supplier Quality Support

Support planning and execution of internal and external audits/assessments, including coordination of requests, readiness support, and timely response packages.

Assist with supplier/vendor quality activities, including issue intake and escalation, documentation review, and follow‑up on corrective actions in…