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 regulations.

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

• Assist AbbVie plants in carrying out supplier Quality Assurance audits.

• Aid in the resolution of CAPA plans associated with supplier Quality Assurance audits.

• Evaluate the adherence of systems, facilities, and procedures to applicable regulations and AbbVie standards.

• Provide audit findings and review corrective actions for proper execution, effectiveness, and sustainability.

• Develop corrective-action suggestions for internal AbbVie locations.

• Engage in strategic efforts aimed at enhancing compliance with regulatory and standard requirements.

• Audit critical suppliers with essential business processes.

• Take part in audits of AbbVie plants.

• Work collaboratively with R&D QA to plan and execute joint audits.

• Coordinate supplier audit activities alongside procurement, SQA, EQA, manufacturing locations, commercial affiliates, and external stakeholders.

• Ensure that audits are conducted according to the established annual audit schedule.

• Mitigate supplier audit delays that could lead to 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.

• Minimum of 4 years of relevant industry experience if substituting for the degree, with familiarity in pharmaceutical, medical device, biologics, combination products, cosmetics, eye care, or aesthetics-related sectors.

• Over 9 years of total relevant experience.

• At least 6 years in Quality Assurance roles.

• A minimum of 3 years in compliance or auditing functions.

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

• ASQ certification is preferred.

• Technical knowledge, including an understanding of Quality Assurance audit methodologies.

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

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

• Grasp of quality management principles.

• Exceptional oral and written communication abilities.

• Strong interpersonal, organizational, administrative, and decision-making skills.

• Capacity to communicate effectively and influence both external parties and internal stakeholders across various functional and technical domains.

🏝️ Benefits

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

• Medical, dental, and vision insurance options.

• 401(k) retirement plan.

• Eligibility to participate in long-term incentive programs.