Lead, Americas Clinical Quality Audit

Allergan; North Chicago (IL); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Long-term incentive programs

Comprehensive benefits package

Paid time off

Job summary

AbbVie seeks a Heads of the Americas Clinical Quality Audit to lead a high-performing team across the Americas, delivering the clinical audit strategy and ensuring quality and compliance of AbbVie trials and studies in the region.

The role requires guiding audits, collaborating with global and regional teams, and advancing the AbbVie Quality System while ensuring alignment with RDQA policies. Domestic and international travel will be required.

Qualifications

• Bachelor’s degree in science (physical, life, health) or equivalent experience.
• 7+ years in pharma with clinical development, regulatory affairs, or QA.
• Detailed knowledge of quality systems and auditing standards.
• Global/regional clinical regulatory requirements and QA practices.
• Excellent communication, negotiation and influencing skills; strong problem solving.

Responsibilities

• Leads and develops the Americas Clinical Auditors team; builds a strategic, high-performing function.
• Contributes to global Clinical Audit strategy and aligns with Americas execution.
• Manages risk-based audit program; conducts complex audits; guides auditees to resolve non-compliance.
• Drives innovative quality strategies; collaborates with partners and other GxP RDQA functions.
• Supports development/improvement of quality systems and regulatory compliance.
• Analyzes processes supporting clinical development to ensure quality and compliance.
• Provides strategic input to inspection support and supports GCP inspections onsite/remotely as needed.
• Promotes continuous education on quality guidelines and regulations for AbbVie staff.

Skills

Quality systems

Auditing standards

Regulatory knowledge

Cross-functional leadership

Strategic thinking

Communication skills

Travel readiness

Education

Bachelor's degree in science/health

Job description

AbbVie seeks a Heads of the Americas Clinical Quality Audit to lead a high-performing team across the Americas, delivering the clinical audit strategy and ensuring quality and compliance of AbbVie trials and studies in the region.

The role requires guiding audits, collaborating with global and regional teams, and advancing the AbbVie Quality System while ensuring alignment with RDQA policies. Domestic and international travel will be required.