Quality Systems Support Manager

Summary

Join AbbVie as a Manager, Quality Systems Support and lead a team in implementing and maintaining quality systems across the global laboratory enterprise. You will oversee projects, develop long-range plans, manage budgets, and ensure compliance with regulatory expectations. This role requires strong leadership, strategic thinking, and experience in quality systems within a regulated environment. You will also be responsible for maintaining communication between sites and global teams. AbbVie offers a comprehensive benefits package including paid time off, health insurance, and participation in incentive programs.

Requirements

• Bachelor’s Degree in Science or Business or Engineering or equivalent work experience
• Compliance and/or QA experience
• Quality system development and implementation
• 10+ years of experience in quality systems or business support in a regulated environment

Responsibilities

• Manage team of 2 direct reports; QA System Specialists
• Oversee projects for implanting new IT Systems, setting robust implementation strategies and tactical implementation plans
• Develop long-range and capital plans to maintain and advance our enterprise systems in alignment with the overall laboratory strategic objectives
• Maintain operating budget for capital and operating expense associated with business owned system maintenance and enhancement
• Maintain global policies for laboratory enterprise systems ensuring compliance with regulatory expectations for software quality assurance, software development lifecycle
• Act as the primary liaison for questions relating to enterprise laboratory systems during site regulatory and third party inspections/audits
• Provide strategic direction and indirect oversight to digital system leads at each laboratory within the enterprise (globally), ensuring alignment with global master data standards and change management practices
• Accountable for the maintenance of communication between sites and global quality/global BTS teams through established routine communication/collaboration forums
• Accountable for successful implementation and sustainability of robust, user friendly, enterprise systems that drive efficient and effective execution of laboratory workflows
• Leveraging AI supporting tools and data automation technologies
• Support implementation of new technologies
• Identify and implement new technologies for QC Operations

Benefits

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