Associate Manager, Quality Assurance (Governance)

 Posted an hour ago
  
 Canada
  
5-10 years experience
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AI Summary

Lead the QA Governance team in managing internal, external, and client audits while overseeing CAPA and supplier quality programs. Develop governance dashboards and KPIs to monitor compliance and present quality insights to leadership and clients.

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, QA Governance 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.  
  • 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? 

Your Mission: 

Audit Governance (Internal, External & Client Audits)

  • Develop and maintain governance dashboards and KPI packages for audits, CAPA, deviations, suppliers, and commitments.
  • Own the Quality Audit Program including risk‑based planning, execution, reporting, and post‑audit governance activities.
  • Lead all internal audits, ensuring audit scopes, tools, documentation, and reports meet QMS and regulatory requirements.
  • Act as the primary QA lead during external and client audits, managing readiness, evidence compilation, SME coordination, and audit execution.
  • Document audit observations with objective, risk‑aligned language and ensure timely, high‑quality responses.
  • Govern the closure of audit‑related action plans and CAPAs, verifying effectiveness, sustainability, and escalation of risks.
  • Maintain audit governance documentation, schedules, templates, and systemic trend analyses.

CAPA & Action Plan Governance

    • Oversee CAPA and action‑plan governance ensuring problem statements, RCAs, risk scoring, and actions meet quality standards.
    • Review CAPA packages for clarity, completeness, effectiveness, and sustainability.
    • Track CAPA timeliness, effectiveness checks, recurrence trends, and escalate systemic issues.

    Supplier Quality Management

    • Lead supplier qualification and re‑qualification including risk tiering, documentation review, and assessments.
    • Govern supplier performance monitoring, issue escalation, and remediation planning.
    • Conduct or oversee supplier audits/assessments and ensure timely closure of findings.
    • Collaborate closely with Procurement, Operations, Clinical, and Pharmacy teams to manage supplier risks.

    Quality Agreements & Compliance Requirements

    • Develop, review, negotiate, and maintain Quality Agreements with clients and suppliers.
    • Ensure agreement expectations are embedded in internal processes and monitored for compliance.
    • Track contractual quality commitments, deliverables, and evidence required for audits.
    • Provide guidance to teams regarding Quality Agreement interpretation and obligations.

    Data Insights & Governance Reporting

    • Develop and maintain governance dashboards and KPI packages for audits, CAPA, deviations, suppliers, and commitments.
    • Analyze trends to identify risks and systemic improvement opportunities.
    • Present concise governance insights to leadership, clients, and cross‑functional teams.
    • Ensure data accuracy, traceability, and integrity in governance systems.

    Stakeholder & Client Governance Partnership

    • Serve as a key QA Governance contact for clients, suppliers, and internal partners.
    • Support client governance meetings with reporting, metrics, audit updates, and quality insights.
    • Lead communications on externally reportable issues and risks to service continuity.

    Leadership & Team Management

    • Lead and coach the QA Governance team, managing workload, performance, and skill development.

    Leadership Responsibilities:

    • Provides clear direction, sets measurable goals, and holds team members accountable for performance and results.
    • Coaches, develops, and supports team members through regular feedback, performance reviews, and career development planning.
    • Fosters a high-performing, inclusive team culture that aligns with company values and business objectives.
    • Foster a culture of compliance, critical thinking, accountability, and continuous improvement.
    • Provide cross‑functional quality leadership and guidance.
    • Act as back‑up for the Manager, QA Governance for escalations, governance decisions, and external interactions.

    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: 7–10 years of progressive QA experience in regulated healthcare, pharmaceutical, clinical, PSP, or GxP environments. Experience owning internal audit programs and leading client/external audit activities. Experience in CAPA governance, supplier quality oversight, and Quality Agreement administration.
    • Skills: Strong knowledge of QMS elements, root cause analysis, and risk-based decision-making. Preferred Certifications: ASQ CQA, CQE, CSQP, Lean Six Sigma Green Belt or higher.
    • 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! 

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