Global Senior Manager, Clinical Quality Assurance

BioSpace; North Chicago (IL); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie, a leading biopharma company, seeks a Senior RDQA AREA Manager to drive quality excellence across global trials. You will oversee regulatory compliance, audit readiness and supplier oversight within designated affiliates, reporting to the AREA leadership.

This hybrid role supports multiple US locations and requires deep QA expertise. The position emphasizes risk-based quality management, collaboration with clinical development teams, and sustaining One AbbVie Quality System standards

Qualifications

• Bachelor's degree in biology, nursing, pharmacy or related medical science.
• 8+ years biopharmaceutical/medical device QA, compliance or clinical research experience.
• 3+ years in leadership positions.
• Strong regulatory understanding and risk management.
• Excellent communication and collaboration skills.
• Ability to foster cross-functional teamwork.

Responsibilities

• Provide support for assigned countries/region and implement proactive quality management activities.
• Maintain collaboration with RDQA functions impacting clinical research.
• Drive AbbVie's Quality System and support first-pass approvals.
• Lead audits, inspections and corrective action plans.
• Develop risk mitigation strategies for clinical research activities.
• Mentor AREA managers and associates in quality initiatives.

Skills

Leadership

Quality systems

Regulatory knowledge

Auditing

Stakeholder management

Risk management

Education

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

Job description

AbbVie, a leading biopharma company, seeks a Senior RDQA AREA Manager to drive quality excellence across global trials. You will oversee regulatory compliance, audit readiness and supplier oversight within designated affiliates, reporting to the AREA leadership.

This hybrid role supports multiple US locations and requires deep QA expertise. The position emphasizes risk-based quality management, collaboration with clinical development teams, and sustaining One AbbVie Quality System standards