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 incorporate procedural changes as necessary.
- Provide routine area specific management support (act as backup to manager for routine management activities).
- Support daily product release activities as applicable to the organization.
- Responsible for driving consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
- Write/ review/ approve exception reports, including high impact and complex ERs impacting multifunctional areas.
- Actively lead/participate on assigned project team(s) to support the product development.
- Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.