Senior Quality Auditor – GMP & Compliance

Initial Therapeutics, Inc.; South Chicago Heights (IL); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Auditor, Audit and Compliance to perform comprehensive audits for regulatory compliance across AbbVie plants, affiliates, quality service areas and suppliers, ensuring quality systems meet GMP requirements and AbbVie standards.

You will support supplier QA audits, coordinate with R&D QA and ensure timely audit execution per the annual schedule, avoiding any product launch delays.

Qualifications

• Bachelor's degree in technical/scientific area or equivalent experience (4+ years) in pharma, biotech, cosmetics or related industries.
• 9+ years total relevant experience, including 6+ years in Quality Assurance and 3+ years in compliance/auditing.
• Up to 40% travel.
• Technical understanding of QA audit processes and GMP requirements.
• Strong communication and interpersonal skills.

Responsibilities

• Assesses compliance of systems, facilities, and procedures with regulations and AbbVie specs.
• Reviews audit observations and corrective actions for effectiveness and closure.
• Coordinates supplier audits and internal site audits with stakeholders.
• Collaborates with R&D QA to plan and execute joint audits.
• Ensures audits follow the annual schedule and avoid launches delays.

Skills

Quality Assurance

Auditing

Regulatory Compliance

Project Management

GMP Regulations

Communication Skills

Education

Bachelor's degree in technical/scientific field

ASQ certification desirable

Job description

AbbVie is seeking a Senior Auditor, Audit and Compliance to perform comprehensive audits for regulatory compliance across AbbVie plants, affiliates, quality service areas and suppliers, ensuring quality systems meet GMP requirements and AbbVie standards.

You will support supplier QA audits, coordinate with R&D QA and ensure timely audit execution per the annual schedule, avoiding any product launch delays.