Senior Audit & Compliance Lead (GMP)

BioSpace; North Chicago (IL); On-site; USD 35,000 - 173,000; Full time

Benefits offered by this job

Paid time off

Health benefits

Dental/Vision insurance

401(k)

Job summary

AbbVie is seeking a seasoned Audit and Compliance Senior Auditor/Lead to perform comprehensive audits for regulatory compliance across US and international sites. You will evaluate quality systems, ensure adherence to GMP standards, and drive corrective actions with cross-functional teams.

This role requires extensive QA/auditing experience, strong communication, and the ability to balance involvement with objectivity to support AbbVie’s quality and safety commitments.

Qualifications

• Bachelor's degree in technical or scientific area with sufficient exposure to pharmaceutical, medical device, biologics and related industries.
• 6+ years total experience including 4+ years in Quality Assurance and 2+ years in compliance/auditing.
• Technical background with understanding of QA audit process and GMP regulatory requirements.
• Knowledge of quality/operational systems supporting facility, product design, development, production, distribution, installation, service and related quality management.

Responsibilities

• Assesses compliance of systems, facilities and procedures per regulations and AbbVie specifications.
• Provides feedback through audit observations and reviews corrective actions for effectiveness and sustainability.
• Participates in strategic initiatives to improve regulatory compliance.
• Collaborates with R&D QA to coordinate and conduct joint audits.
• Communicates and coordinates supplier audit activities with internal and external stakeholders.
• Ensures audits follow the annual schedule and are conducted properly.
• Ensures no product launch delays or business interruptions due to supplier audits.

Skills

Communication skills

Interpersonal skills

Judgment

Organizational skills

Influence others

Self-reliance

Education

Bachelor's degree in technical/scientific field

ASQ certification desired

Job description

AbbVie is seeking a seasoned Audit and Compliance Senior Auditor/Lead to perform comprehensive audits for regulatory compliance across US and international sites. You will evaluate quality systems, ensure adherence to GMP standards, and drive corrective actions with cross-functional teams.

This role requires extensive QA/auditing experience, strong communication, and the ability to balance involvement with objectivity to support AbbVie’s quality and safety commitments.