Senior Auditor, Supplier Audit – Compliance

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Conduct thorough audits to ensure compliance with both US and international regulatory standards.

• Assess quality-related systems across AbbVie plants, affiliates, quality service areas, and suppliers.

• Assist in Supplier Quality Assurance audits and the resolution of associated CAPA plans.

• Evaluate the compliance of systems, facilities, and procedures in relation to applicable regulations and AbbVie standards.

• Provide audit findings and review corrective actions to ensure proper implementation, effectiveness, and sustainability.

• Develop recommendations for corrective actions applicable to internal sites.

• Engage in strategic initiatives aimed at enhancing compliance with regulatory requirements and standards.

• Perform audits on key suppliers and potentially on AbbVie plants.

• Work alongside R&D Quality Assurance to coordinate and execute joint audits.

• Organize supplier audit activities in collaboration with procurement, SQA, EQA, manufacturing sites, and commercial affiliates.

• Ensure that audits adhere to the established annual audit schedule.

• Mitigate supplier audit delays to prevent potential product launch setbacks or business interruptions.

⛳️ Requirements

• Bachelor’s Degree in a technical or scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience of at least 4 years.

• Over 9 years of relevant experience in total.

• A minimum of 6 years in Quality Assurance roles.

• Some experience in project management within the pharmaceutical, medical device, biotechnology, or related industries.

• At least 3 years of experience in compliance and auditing.

• A technical background with a solid understanding of Quality Assurance audit processes.

• Familiarity with global GMP regulations concerning quality systems and compliance.

• Insight into quality and operational systems that support facility, product design, development, production, distribution, installation, support, and service.

• Comprehension of quality management principles.

• Exceptional oral and written communication skills.

• Strong interpersonal, organizational, administrative, judgment, self-reliance, tact, open-mindedness, maturity, and tenacity abilities.

• Capability to communicate effectively and influence both internal and external stakeholders.

• ASQ certification is preferred.

• Willingness to travel up to 40% of the time.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility for a long-term incentive program.