Senior Manager, Clinical Quality Assurance

AbbVie

. Support assigned countries and region through proactive quality management activities .

Posted 11/2/2026full-timeRemote • CanadaSenior💰 CA$130,000 - CA$180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management and compliance within regulated environments, with a strong focus on risk identification and mitigation strategies for clinical research. Proven ability to lead teams and foster collaboration across functions while maintaining regulatory preparedness and driving quality excellence.

Highest-signal resume keywords

Quality ManagementRegulatory ComplianceClinical ResearchLeadership ExperienceAuditing Standards

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsRisk ManagementAudit ConductingRegulatory RequirementsInspection ReadinessCorrective Action PlansData AnalysisTrend IdentificationMitigation StrategiesCompliance Assessment

Soft Skills

LeadershipCommunicationCollaborationNegotiationInfluencing

Industry Keywords

BiopharmaceuticalMedical DeviceQuality AssuranceRegulatory AffairsClinical TrialsHealth Authority InspectionsGovernanceCross-Functional CollaborationStakeholder EngagementAudit Responses

About the role

Key responsibilities & impact

Support assigned countries and region through proactive quality management activities
Maintain collaborative relationships with RDQA functions and clinical research stakeholders in designated Affiliates
Advance the AbbVie Quality System and drive quality excellence toward first-pass health-authority approval
Oversee quality and compliance in a regulated environment
Develop risk identification, mitigation, and control strategies for clinical research and clinical trials
Establish quality measures and drive quality strategy in assigned countries and region
Manage fit-for-purpose governance and oversight under the One AbbVie Quality System
Identify trends, root causes, and risks affecting clinical research
Maintain regulatory preparedness and monitor applicable regulations
Support supplier visits, audits, and vendor qualifications
Develop inspection strategy and provide inspection-readiness support for local and regional Health Authority inspections
Provide oversight, support, and follow-up for Health Authority inspections
Participate in Health Authority inspections as needed
Determine the need for country/process assessments and audits
Conduct audits to assess compliance with regulations, guidelines, policies, procedures, and sponsor requirements
Communicate audit results orally and in writing
Review and approve corrective action plans and audit responses
Support robust audit and inspection responses through coaching and education
Mentor AREA Managers, AREA Associates, or line management

Requirements

What you’ll need

Bachelor's degree required, preferably in Biology, Nursing, Pharmacy, or another medical science discipline, combined with equivalent technical experience
8+ years of biopharmaceutical, medical device, quality assurance, compliance, regulatory affairs, clinical research, or related development experience
3 years of experience in leadership positions involving people and/or initiatives/projects
Strong understanding of local and global regulatory and legal requirements and regulatory agency perspectives
Ability to manage strategic risk amid evolving global regulations and expectations
Thorough knowledge of quality systems, auditing standards, and quality management
Strong analytical, organizational, leadership, communication, negotiation, influencing, collaboration, and networking skills
Ability to work effectively with business partners at all levels and foster cross-functional collaboration
Fluent in additional languages desirable but not required
Ability to travel as needed in AREA, up to 35%

Benefits

Comp & perks

Remote work options
Equal opportunity employer
Travel as needed in AREA, up to 35%