Associate Manager, Quality Assurance (Operations)
Department:
Job Summary
Empowering lives healing hearts embracing future
Are you ready to make a lasting impactinspecialty careWereseekinga 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 whyyoulllove it here!):
- Epic Work-Life Balance:Flexible remote work options because we value your time and well-being. â
- Growth Opportunities:Committed to fostering a culture of growth where everyteammember is encouraged to pursue new skills expand their knowledge and advance their careers.
- Vibrant Culture:Over 1500 team members across Canada and year over year we manage tomaintainan overall above industry engagement score by using a monthly pulse survey.
- Our People Say It Best:â Compensation:Competitive salary incentive program and comprehensive benefits package.ââ
- What & Where: Remote & Full-Time Permanent
- Closing Date: June 24 2026
WhyBioScript Solutions
AtBioScriptwerenot just a companywereafast-growingcompany always putting patients as one ofCanadas 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: Bachelors 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.
Wereproud to be an equal opportunity employer.âAs a people-centric organizationwerecommitted to fostering aâwelcomingâculture free of discrimination andâtoâproviding aâhealthy andâsafeâwork environmentâwhereâall team membersâcanâthrive as individuals.âThrough 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 accordance withapplicable provincial legislation including Quebecs Charter of the French Language this job posting is provided in both French and English whenrequired. For positions based in Quebec French languageproficiencyisrequiredto perform day-to-day duties. Bilingualism (French and English) isrequiredfor this position to effectively communicate with internal and external stakeholders.
We encourageand 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
Ready to make your markIfyourepassionate about transforming ideas into extraordinary results and excited to join a forward-thinking team we want to hear from you!
Required Experience:
Manager