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:  https://www.youtube.com/watch?v=gySeQnPY7Tg 

• 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 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 is determined within a range. Our pay ranges are based on the local cost of labor benchmarks for each specific role, level, and geographic location.  

We're proud to be an equal opportunity employer. As a people-centric organization, we’re committed to fostering a welcoming culture free of discrimination, and to providing a healthy and safe work environment where all team members can thrive as individuals. Through our commitment to diversity, inclusion, belonging, and equity, we strive to provide an accessible workplace, where individuals feel valued, respected, and supported every day. 

We are committed to creating an inclusive and accessible work environment across Canada. In accordance with applicable provincial legislation, including Quebec’s Charter of the French Language, this job posting is provided in both French and English when required. For positions based in Quebec, French language proficiency is required to perform day-to-day duties. Bilingualism (French and English) is required for this position to effectively communicate with internal and external stakeholders.    

We encourage and accept all applications, however, only candidates selected for interviews will be contacted. Accommodations can be made available on request for candidates taking part in all aspects of the selection process. For inquiries, please email the talent acquisition team at recruitment@bioscript.ca.  

Ready to make your mark? If you’re passionate about transforming ideas into extraordinary results and excited to join a forward-thinking team, we want to hear from you!