Senior Manager, Clinical Quality Assurance

AbbVie

. Support assigned countries and region through implementation and execution of proactive quality management activities .

Posted 11/2/2026full-timeRemote • CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in quality assurance and compliance within the biopharmaceutical industry, with a strong focus on regulatory requirements and quality management systems. Proven ability to lead teams, drive quality strategies, and ensure inspection readiness while fostering collaboration across functions.

Highest-signal resume keywords

Quality AssuranceRegulatory ComplianceLeadership ExperienceAuditing StandardsQuality Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsRegulatory AffairsClinical ResearchRisk IdentificationData AnalysisAudit ConductingInspection ReadinessCorrective Action PlansQuality Strategy DevelopmentContinuous Improvement

Soft Skills

Effective LeadershipExcellent CommunicationNegotiation SkillsCollaboration AbilitiesTeam Building

Industry Keywords

BiopharmaceuticalMedical DeviceHealth Authority InspectionsCompliance RegulationsClinical TrialsRegulatory AgencyQuality MeasuresGovernance OversightSupplier AuditsCross-Functional Collaboration

About the role

Key responsibilities & impact

Support assigned countries and region through implementation and execution of proactive quality management activities
Maintain collaborative relationships with RDQA functions impacting clinical research within designated Affiliates
Establish relationships with clinical development leaders and staff to advance the AbbVie Quality System and achieve first-pass health-authority approval
Oversee quality and compliance in a regulated environment, including AbbVie policies, procedures, and country/regional standards and regulations
Lead or collaborate on risk identification and mitigation/control strategies for clinical research and clinical trials
Review quality and compliance data periodically for continuous improvement
Establish quality measures and drive quality strategy in designated countries and region
Manage fit-for-purpose governance and oversight under the One AbbVie Quality System
Identify trends, root causes, and potential risks affecting clinical research
Drive continuous regulatory preparedness
Work with Affiliates R&D Management on Quality System health and quality/compliance issues
Maintain awareness of applicable regulations and develop quality standards for assigned countries and region
Support supplier visits, audits, and vendor qualifications
Develop inspection strategy and provide inspection-readiness support for local/regional Health Authority inspections
Provide oversight, support, and follow-up for inspection reports
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 as an additional lead responsibility
Report to the RDQA Associate Director or RDQA Global Director, AREA

Requirements

What you’ll need

Bachelor's degree required, preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience
8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions
3 years in leadership positions (people and/or initiatives/projects)
Strong understanding of local and global regulatory and legal requirements and regulatory agency approaches and perspectives
Ability to ensure strategic risk focus with evolving global regulations and expectations
Agile and able to respond rapidly to unplanned events and changing regulatory requirements and expectations
Thorough knowledge of quality systems, auditing standards and quality management
Strong analytical skills and ability to organize work in a logical, thorough and succinct manner
Effective leadership in interactions with business partners at all levels
Excellent written and oral communication skills, including presentation and influencing skills
Strong negotiation, influencing and collaborating abilities with excellent networking skills
Ability to foster cross-functional collaboration teams
Strong team player or team lead who builds relationships with peers and cross-functionally at global and local levels
Fluent in additional languages desirable but not required
Ability to travel as needed in AREA (up to 35%)

Benefits

Comp & perks

Employees can work remotely
Equal opportunity employer
Reasonable accommodation for US & Puerto Rico applicants
Travel as needed in AREA (up to 35%)