Associate Manager,Quality Assurance; Operations Job Oakville Ontario Canada,Quality Assurance

Position: Associate Manager, Quality Assurance (Operations)

Empowering lives, healing hearts, embracing future

Are you ready to make a lasting impact in specialty care? We’re seeking a dedicated and dynamic Associate Manager, Quality Assurance (Operations) to join our team at BioScript Solutions, where we put our patients first!

What we offer (and why you’ll love it here!):

Epic Work-Life Balance: Flexible remote work options because we value your time and well-being.

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

Vibrant Culture: Over 1,500 team members across Canada and year over year we manage to maintain an overall above industry engagement score by using a monthly pulse survey.

Our People Say It Best:

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

What & Where: Remote & Full-Time, Permanent

Closing Date: June 24, 2026

Why BioScript Solutions?

At BioScript, we're not just a company—we're a fast-growing company always putting patients first. Recognized as one of Canada’s Best Managed Companies, we believe in pushing boundaries, setting trends, and creating meaningful experiences that captivate and inspire. Our vibrant team is made up of innovative minds who are passionate about driving success and making an impact. Ready to be a part of this exhilarating journey?

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.

Ensure investigations are performed to a consistent standard (problem statement, containment/corrections, root cause analysis, risk evaluation, and documentation), partnering with Operations/Clinical/Pharmacy/IT as needed.

Maintain high-quality, audit-ready records that meet documentation and data integrity expectations; ensure clear, objective writing and traceable evidence to support decisions.

Escalate quality risks, overdue events, or recurring issues; facilitate cross-functional problem solving to drive timely containment and sustainable resolution.

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.

Coach teams on root cause analysis and robust action plans (containment, corrective, preventive, systemic actions); challenge weak fixes and ensure owners, milestones, and due dates are defined and met.

Ensure CAPA effectiveness checks are planned and executed; verify sustained implementation and measurable risk reduction; escalate when actions are ineffective or trends persist.

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.

Ensure impact assessments address patient safety, regulatory/customer requirements, data integrity, and business continuity; confirm implementation activities (training, document updates, validation/verification as applicable) are completed.

Drive timely closure through change effectiveness/review where required; maintain an audit-ready change control 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 and aging, investigation and CAPA cycle time, 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 (procedure updates, training, error-proofing, workflow simplification) and present recommendations to leadership.

Apply structured improvement methods (e.g., Lean/DMAIC) to reduce investigation/CAPA cycle time, improve right-first-time 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; partner cross-functionally to embed sustainable controls and prevent recurrence.

Stakeholder & Client Partnering (Quality Governance)

Provide QA Operations governance support to internal stakeholders and, as applicable, to 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, and 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 (as…

Associate Manager, Quality Assurance; Operations