Principal Auditor

Summary

Join AbbVie as a Principal Auditor, Audit & Compliance and provide leadership in conducting comprehensive audits to ensure compliance with US and foreign regulations. You will assess compliance of systems and procedures, provide feedback on corrective actions, and lead initiatives to improve compliance. This role requires significant travel (50-75%) and collaboration with internal and external stakeholders. The ideal candidate possesses a strong technical background in quality assurance and auditing within the pharmaceutical or related industry, along with excellent communication and interpersonal skills. AbbVie offers a comprehensive benefits package including paid time off, health insurance, and participation in short-term and long-term incentive programs.

Requirements

• Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries
• ASQ certification desired
• 9+ years of total relevant experience, including 6+ years in Quality Assurance with some management experience preferred and 3+ years in the pharmaceutical, medical device, biotechnology or related industry and 4+ years in compliance/auditing or regulatory affairs is desirable
• Must have a technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance
• Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support, and service and understand the principles of quality management
• Excellent oral/written communications skills
• Must exhibit strong interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment
• Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas

Responsibilities

• Requires 50-75% Travel
• Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications
• Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions
• Leads and participates in strategic initiatives to improve compliance to regulatory requirements and standards
• For supplier auditing, primarily focused on key suppliers whose processes are more comprehensive and critical to the business and will include potential participation in audits of AbbVie plants
• Collaborates with R&D QA to coordinate and conduct joint audits
• Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders
• Ensures audits are conducted according to the annual audit schedule
• Plays an active role within the corporation as experts in GMP requirements. Strategically focused on early detection and prevention, followed by correction of issues

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs