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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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…