Senior Associate, Product Development Quality

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:

This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch
disposition activities and ensuring high-quality clinical supplies that are compliant with global
regulatory requirements and standards are delivered to patients. This is achieved by effectively
partnering with the business, ensuring risks are mitigated appropriately and supporting efficient
review of clinical supply batches to support continued uninterrupted access to clinical supplies.
The successful candidate will be able to manage multiple tasks and adjust priorities based on
supply needs. This position requires the ability to positively interact with multiple functional
areas quickly and effectively resolve batch record documentation related issues independently,
ensuring schedules are maintained and material is readily available.

Responsibilities:
List up to 10 responsibilities of the job including information regarding scope and accountability.

• Review and approve batch records and release batches or analytical records.
• Write/ review/ approve processes/procedures and related documents.
• Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in the materials management system as defined by procedures.
• Write, review and/or approve exception documents and product complaints (as applicable), corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
• Review/approve clinical documentation and specifications, as applicable.
• Actively lead/participate on assigned project team(s) to support