Senior Global Clinical Quality Assurance Lead

BioSpace; North Chicago (IL); Hybrid; USD 140,000 - 200,000; Full time

Job summary

AbbVie is seeking a RDQA AREA Senior Manager to lead quality assurance efforts across assigned countries and regions within the global development lifecycle. You will drive proactive quality management, uphold the One AbbVie Quality System, and ensure regulatory alignment for clinical research activities.

You will collaborate with clinical development leaders, manage inspections and audits, and mentor AREA staff to sustain continuous improvement in quality and compliance.

Qualifications

• Bachelor's degree in Biology, Nursing, Pharmacy, or other medical science degree with equivalent technical experience.
• 8+ years in biopharmaceutical/medical device quality assurance, compliance, regulatory affairs, clinical research or related development functions, including 3 years in a lead role.
• Strong understanding of local and global regulatory requirements and regulatory perspectives.
• Ability to maintain strategic risk focus amid evolving global regulations and expectations; agile and adaptable.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Motivates and influences others, including those without direct authority.
• Strong analytical skills with structured, concise communication.
• Ability to work at an experienced level, leading collaboration with partners at all levels.
• Excellent written & oral communication, presentation and influencing skills.
• Strong negotiation, influencing and cross-functional collaboration abilities.
• Ability to foster cross-functional teams across functions.

Responsibilities

• The RDQA AREA Senior Manager will provide support for the assigned countries and region and will be responsible for the implementation/execution of activities related to proactive quality management.
• Maintain a close, collaborative relationship with RDQA functions impacting clinical research.
• Establish collaborative working relationships with clinical development leaders to advance the AbbVie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities.
• Oversee quality and compliance in a regulated environment including AbbVie policies and procedures and country/regional standards.
• Lead and/or collaborate on risk identification and mitigation for clinical research activities including trials with periodic reviews of quality data for improvement.
• Establish quality measures to achieve RDQA goals and drive quality strategy in designated countries/region with RDQA AREA personnel.
• Manage governance/oversight that aligns with One AbbVie Quality System; identify trends, root causes, and mitigate risks.
• Ensure understanding of quality requirements within Affiliates; work with R&D management on health of Quality System, and identify issues.
• Maintain awareness of applicable regulations and develop standards to measure quality in assigned countries/region for clinical research.
• Support Necessary Supplier Visits, Audits And Vendor Qualifications
• Develop inspection strategy in collaboration with AREA Associate Director and provide inspection-readiness for local/regional Health Authority inspections.
• Provide oversight and follow-up for Health Authority inspections; participate as needed.
• Determine need for country/process assessments/audits in collaboration with Clinical Audit and Clinical PM.
• Conduct audits to assess compliance; communicate results; review and approve CAPA/audit responses.
• Support development of robust audit/inspection responses through coaching and education.
• Mentor AREA Managers/AREA Associates or line management as needed.

Skills

Regulatory compliance

Quality systems

Audit management

Education

Bachelor's degree in Biology, Nursing, Pharmacy, or related medical science

Job description

AbbVie is seeking a RDQA AREA Senior Manager to lead quality assurance efforts across assigned countries and regions within the global development lifecycle. You will drive proactive quality management, uphold the One AbbVie Quality System, and ensure regulatory alignment for clinical research activities.

You will collaborate with clinical development leaders, manage inspections and audits, and mentor AREA staff to sustain continuous improvement in quality and compliance.