Senior Auditor, Supplier Audit – Compliance

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $109.5k - $208.5k / year

⏰ Full Time

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Perform comprehensive audits for compliance with US and foreign regulations • Evaluate quality-related systems for AbbVie plants, affiliates, quality service areas, and suppliers • Support AbbVie plants in executing supplier Quality Assurance audits • Support resolution of CAPA plans related to supplier Quality Assurance audits • Assess compliance of systems, facilities, and procedures against applicable regulations and AbbVie specifications • Provide audit observations and review corrective actions for proper implementation, effectiveness, and maintenance • Formulate corrective-action recommendations for internal AbbVie sites • Participate in strategic initiatives to improve regulatory and standards compliance • Audit key suppliers with comprehensive and business-critical processes • Participate in audits of AbbVie plants • Collaborate with R&D QA to coordinate and conduct joint audits • Coordinate supplier audit activities with procurement, SQA, EQA, manufacturing sites, commercial affiliates, and external stakeholders • Ensure audits follow the annual audit schedule • Prevent supplier audit delays from causing product launch delays or business interruptions

🎯 Requirements

• Bachelor’s Degree, preferably in a technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering), or equivalent industry experience • At least 4 years of equivalent industry experience if substituting for the degree, with exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care, or aesthetics-related industries • 9+ years of total relevant experience • 6+ years in Quality Assurance • 3+ years in compliance/auditing • Some project management experience in the pharmaceutical, medical device, biotechnology, or related industry • ASQ certification desired • Technical background, including understanding of Quality Assurance audit processes • Knowledge of worldwide GMP regulations for quality systems and compliance • Understanding of quality/operational systems supporting facility, product design, development, production, distribution, installation, support, and service • Understanding of quality management principles • Excellent oral and written communication skills • Strong interpersonal, organizational, administrative, and judgment skills • Ability to communicate effectively with and influence external parties and internal stakeholders across functional and technical areas

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in long-term incentive programs