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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in quality assurance and compliance within the biopharmaceutical and medical device industries, with a strong focus on regulatory requirements and quality management systems. Proven ability to lead cross-functional teams and manage risk in clinical research environments.
Highest-signal resume keywords
Quality AssuranceRegulatory ComplianceClinical ResearchLeadership ExperienceAuditing Standards
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ManagementRegulatory AffairsRisk IdentificationAudit ConductingInspection ReadinessCorrective Action PlansQuality System DevelopmentData AnalysisTrend IdentificationCompliance Assessment
Soft Skills
Analytical SkillsOrganizational SkillsWritten CommunicationOral CommunicationCollaboration
Industry Keywords
BiopharmaceuticalMedical DeviceHealth Authority InspectionsClinical TrialsRegulatory RequirementsQuality StandardsGovernanceVendor QualificationsCross-Functional CollaborationStrategic Risk Focus
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 supporting clinical research in 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 under AbbVie policies, procedures, and applicable country and regional standards
- Lead or collaborate on risk identification, mitigation, and control strategies for clinical research and clinical trials
- Establish quality measures and drive quality strategy in designated countries and region
- Manage fit-for-purpose governance and oversight within the One AbbVie Quality System
- Identify trends, root causes, and risks affecting clinical research
- Maintain regulatory preparedness and support Affiliates R&D Management on Quality System health
- Maintain awareness of applicable regulations and develop quality standards for assigned countries and region
- Support supplier visits, audits, and vendor qualifications
- Develop inspection strategies and provide inspection-readiness support for local and regional Health Authority inspections
- Provide oversight, support, follow-up, and inspection-report responses 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 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 another medical science, combined with equivalent technical experience
- 8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or related development functions
- 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 approaches
- Ability to maintain a strategic risk focus amid evolving global regulations and expectations
- Thorough knowledge of quality systems, auditing standards, and quality management
- Strong analytical, organizational, written, oral communication, presentation, negotiation, influencing, collaboration, and networking skills
- Ability to work at an experienced level and lead interactions with business partners at all levels
- Ability to 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- Employees can work remotely
- Travel as needed in AREA (up to 35%)
- Equal opportunity employment
- Reasonable accommodation for US & Puerto Rico applicants