Future Opportunities - Join Our Talent Pipeline for Supervisor, Audit

Qualifications

• Bachelor’s Degree, preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years)
• Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries
• ASQ certification desired
• 6+ years of total relevant experience, including 4+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device, biotechnology or related industry and 2+ years in compliance/auditing
• Technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance
• Understanding of a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support, and service and principles of quality management
• Excellent oral/written communications skills
• Strong interpersonal skills, tact, open-mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment
• Ability to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas

Responsibilities

• Audits 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
• Formulates recommendations for corrective actions
• Participates in strategic initiatives to improve compliance to regulatory requirements and standards
• 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
• Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring supply to AbbVie patients