Director, Quality Systems

Quality Systems Director

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

Purpose

The Quality Systems Director serves as a leading subject matter expert and project manager for the continuous improvement of the AbbVie Quality System. As such, the QS Director must maintain current subject matter expertise in the latest developments in global pharmaceutical quality systems. In addition, the QS Director must be able to integrate and facilitate the formation of the Device Quality System both as a part of the AbbVie QS and as individual plant quality systems. The QS Director also serves as the Operations Coordinator of the Regulatory Intelligence Process. As such, they are responsible for the capture, dissemination and implementation of technical and regulatory new global guidelines and emerging regulations.

Responsibilities

• Serve as Operations Quality Plan Coordinator and ensure compliance with all quality plan requirements for both drug and device quality systems.
• Participate and lead long-duration teams formed to drive process harmonization, site-to-site consistency, sustainability and efficiency.
• Complete all transition activities for company separation duties; particularly for document hierarchy across the three functional areas.
• Manage the Quality System and Centers of Excellence to ensure alignment with regulatory standards and guidance. Drive a continuous improvement philosophy to ensure the CoEs are being managed to deliver a quality system that consistently meets regulatory requirements. Drive alignment of CoE activities with the Global Operations Quality strategy.
• Serve on short duration teams chartered with achieving synergies with other Quality organizations (e.g.-R&D and Regulatory).
• Serve as a key leader in knowledge management processes via Regulatory Intelligence Process that better enable AbbVie to achieve an improved, current and contemporary quality system.

Qualifications

• Position requires BS degree in a science related area.
• 10+ years of Quality, Regulatory and/or Operations experience with significant situational leadership experience.
• This role requires strong organizational skills, strategic thinking, project management leadership skills and strong understanding of the pharmaceutical business.
• The incumbent must also have a solid understanding of the quality and regulatory requirements of the medical device regulations.
• Requires an in-depth understanding of the pharmaceutical product development cycle.
• The position requires human relations and administrative skills necessary to establish and maintain effective working relationships with team members, co-leaders and senior management in quality, manufacturing, supply chain, finance, information systems, and engineering.
• The individual must possess sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations.
• Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed.
• Excellent presentation and interpersonal skills required.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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