Associate Manager, Quality Assurance – Governance

Responsibilities

• 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.
• 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 escalated systemic issues.
• Lead supplier qualification and re‑qualification including risk tiering, documentation review, and assessments.
• Govern supplier performance monitoring, issue escalation, and remediation planning.
• Collaborate closely with Procurement, Operations, Clinical, and Pharmacy teams to manage supplier risks.
• Develop, review, negotiate, and maintain Quality Agreements with clients and suppliers.
• Track contractual quality commitments, deliverables, and evidence required for audits.
• Provide guidance to teams regarding Quality Agreement interpretation and obligations.
• 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.
• 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.
• Lead and coach the QA Governance team, managing workload, performance, and skill development.
• 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. Act as back‑up for the Manager, QA Governance for escalations, governance decisions, and external interactions.

Requirements

• 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.