Associate Manager, Quality Assurance (Operations)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 applicable), including coordination of requests, readiness support, and timely response packages.
- Assist with supplier/vendor quality activities, including quality issue intake and escalation, documentation review, and follow-up on corrective actions in alignment with internal requirements.
- Contribute to quality agreement inputs and periodic reviews (as applicable) to ensure expectations for quality events, CAPA, change controls, and reporting are clear and implementable.
- Track audit commitments and supplier corrective actions through closure, ensuring appropriate linkage to investigations/CAPAs and visibility of status, risk, and due dates.
Leadership / Working Relationships - Reports to the QA Manager and provides day-to-day leadership for a QA Operations team, including work prioritization, resource planning, and assignment of investigations/CAPA/change controls.
- Builds strong partnerships with Operations/Clinical/Pharmacy, Procurement, IT, and other support functions to remove roadblocks, manage risk, and ensure consistent Quality System execution.
- Develop and mentor team members through onboarding, coaching, quality standards calibration, and career development plans; provide regular feedback, address performance gaps, and foster a culture of accountability and continuous improvement.
- Act as back-up/acting Manager, QA as required, providing escalation support, decision making, and communication of quality risks and performance to senior stakeholders.
What You Bring to the Table:- Education: Bachelor's degree in life sciences, pharmacy, nursing, health administration, quality, or a related discipline (or equivalent combination of education and experience).
- Experience: 5+ years of progressive quality experience in a regulated healthcare environment (PSP, clinical services, specialty pharmacy, distribution/logistics, or GxP) with demonstrated ownership of investigations/deviations/incidents, CAPA, and change control; prior people leadership or strong experience leading teams/cross-functional initiatives preferred.
- Skills: Strong working knowledge of investigation practices, CAPA governance, and change control; effective root cause analysis and risk-based decision making; excellent documentation and stakeholder communication; strong organization and ability to manage priorities/aging items; ability to translate metrics and trending into actionable insights; demonstrated coaching/people leadership capability. Experience with structured problem-solving and continuous improvement methodologies (e.g., DMAIC, Lean, A3, 8D) is an asset.
- English proficiency is required for this position to effectively communicate with internal and external stakeholders.
- Bilingualism (French and English) may be required depending on the specific role, location, and the needs of the organization
Compensation:At BioScript, your base pay is one part of your total compensation package and isdeterminedwithin a range. Our pay ranges are based on the local cost of laborbenchmarks for each specific role, level, and geographic location.
Ready to make your mark?Ifyou'repassionate about transforming ideas into extraordinary results and excited to join a forward-thinking team, we want to hear from you!
