FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
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 affairs and clinical research. Proven ability to lead teams, manage quality systems, and ensure adherence to local and global regulatory standards.
Highest-signal resume keywords
Quality AssuranceRegulatory AffairsClinical 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 ComplianceRisk IdentificationAudit ConductingInspection ReadinessData AnalysisCorrective Action PlanningQuality System DevelopmentTrend AnalysisGovernance Oversight
Soft Skills
Effective CommunicationNegotiation SkillsCollaborationInfluencing SkillsTeam Leadership
Industry Keywords
BiopharmaceuticalMedical DeviceHealth Authority InspectionsClinical TrialsRegulatory RequirementsQuality StandardsCross-Functional CollaborationSupplier AuditsRisk MitigationContinuous Improvement
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 and regional standards and regulations
- Lead or collaborate on risk identification and mitigation/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 under the One AbbVie Quality System
- Identify trends, root causes, and risks affecting clinical research
- Drive continuous regulatory preparedness and monitor the health of the Quality System with Affiliates R&D Management
- 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 Health Authority inspections and participate 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
- 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 logically, thoroughly, and succinctly
- Ability to work at an experienced level and demonstrate effective leadership with business partners at all levels
- Excellent written and oral communication, presentation, and influencing skills
- Strong negotiation, influencing, collaborating, and networking abilities
- 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
- Ability to travel as needed in AREA (up to 35%)
Benefits
Comp & perks- Employees can work remotely
- Equal opportunity employer
- Travel as needed in AREA (up to 35%)