Clinical Trial Assistant supporting MRI data, documentation, and site coordination for NeuroRx Research’s neurology clinical trials. Providing administrative and quality - control support to Project Managers.
About the role
- Senior Clinical Quality Assurance Manager advancing AbbVie’s innovative medicines through compliant clinical research. Driving quality systems, audits, risk management, and inspection readiness across Canadian affiliates.
Responsibilities
- 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
- 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
- Remote work options
- Equal opportunity employer
- Travel as needed in AREA, up to 35%
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