Manager, Product Development Quality Assurance
About the role
About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 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, mentor and coach peers, and quickly and effectively be able resolve batch record documentation related issues independently, ensuring schedules are maintained and material is readily available.
Responsibilities
- 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.
- Review draft and final regulation for impact to R&D business and