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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 industry, with a strong focus on regulatory affairs and clinical research. Proven ability to lead teams, manage quality systems, and drive strategic risk management initiatives across diverse regions.
Highest-signal resume keywords
Quality AssuranceRegulatory AffairsClinical ResearchLeadership ExperienceQuality Management Systems
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 SystemsAuditing StandardsRegulatory ComplianceRisk ManagementData AnalysisCorrective Action PlansInspection ReadinessClinical Trials OversightTrend AnalysisRoot Cause Analysis
Soft Skills
Analytical SkillsOrganizational SkillsWritten CommunicationOral CommunicationCollaboration Skills
Industry Keywords
Biopharmaceutical IndustryMedical Device IndustryHealth Authority InspectionsClinical DevelopmentRegulatory RequirementsVendor QualificationsAudit ResponsesContinuous ImprovementCross-Functional CollaborationGlobal Regulations
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 country/regional standards
- Lead or collaborate on risk identification and mitigation/control strategies for clinical research and clinical trials
- Review quality and compliance data to support continuous improvement and establish quality measures
- Drive quality strategy across designated countries and region with RDQA AREA personnel
- Manage fit-for-purpose governance and oversight aligned with 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 strategy and provide inspection-readiness support for local and regional Health Authority inspections
- Provide oversight, support, and follow-up for inspection reports and participate in inspections as needed
- Determine need for country/process assessments and audits; conduct audits as required
- 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
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
- At least 3 years 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 apply strategic risk focus amid evolving global regulations and expectations
- Agile response to unplanned events and changing regulatory requirements and expectations
- Thorough knowledge of quality systems, auditing standards, and quality management
- Strong analytical, organizational, written, oral communication, presentation, negotiation, influencing, and collaboration skills
- Ability to work effectively with business partners at all levels
- Ability to foster cross-functional collaboration and build global and local relationships
- Fluent in additional languages desirable but not required
- Ability to travel as needed in the AREA, up to 35%
Benefits
Comp & perks- Remote work available
- Equal opportunity employment
- Reasonable accommodation for US and Puerto Rico applicants
- Opportunity to work on innovative medicines and solutions addressing serious health issues
- Professional mentoring responsibilities and leadership development through mentoring