Senior Specialist, Quality Systems

Company Description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilities

• Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Responsible for developing a process to maintain citation history.

• Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the AbbVie 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 as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to dete