Senior Specialist, Quality Systems

Position Overview

Location: Lincoln

Abb Vie’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. For more information about Abb Vie, please visit our social media channels.

The Sr Specialist Quality Systems is responsible for providing quality assurance support for one or more of the following manufacturing processes:

Key Responsibilities

• Ensure proper integration and support of quality regulations for drugs, biologics, devices, and/or combination products.
• Assist project teams with planning, preparation, review, and approval of quality documentation.
• Develop a process to maintain citation history.
• Monitor changes to legislation, regulations, and statutes that may impact retention and/or require changes to the Abb Vie Record Retention Schedule.
• Create quality system documentation and specifications with guidance from technical teams, following approved templates and guidelines.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Design effective quality systems, procedures, and/or processes within cross-functional teams to ensure compliance and efficiency, including preparing and presenting data during regulatory and internal audits.
• Interact with internal and external partners to develop best practices in quality systems and procedures.
• Perform assessments to determine process and regulation compliance, identify potential gaps, and implement improvements.
• Contribute to and prepare training and education programs for various aspects of quality assurance.

Required Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or another technical/scientific area is preferred.
• 5+ years of experience in quality assurance, quality oversight, or a related field.
• Technical knowledge in quality, regulatory, process sciences, and manufacturing operations.
• Familiarity with product, process, equipment, and facility requirements related to pharmaceutical, biological, or device products.
• Knowledge of QA systems and GMP compliance requirements, including regulations and standards for devices, biologics, and pharmaceutical products.
• Ability to work both independently and within a team setting, managing time effectively with manager guidance.
• Strong oral and written communication skills across all levels of management.
• Proven experience in running and managing small to medium-sized quality-related projects.

Benefits & Perks

• Benefits: Comprehensive package including paid time off (vacation, holidays, sick leave), medical/dental/vision insurance, and 401(k) for eligible employees.
• Eligible to participate in short-term incentive programs.