Ensure GxP compliance to AbbVie policies/processes/procedures, global regulatory requirements, and industry guidelines. Remain current with major compliance trends and their application within the biopharmaceutical industry.
Role Overview:
Serve as a business compliance liaison for Development Sciences (Dev Sci) scientific personnel involved in pipeline research and product development. Collaborate with cross-functional teams, including personnel from Dev Sci, other R&D groups, including QA, and AbbVie Operations, to ensure compliance with relevant policies, regulations, and industry standards throughout all research and development activities.
Key Responsibilities
- Ensure compliance with Quality System (QS) documents, including the creation, modification, and management of QS documents.
- Collaborate as part of a global document management team, engaging with cross-functional stakeholders at all organizational levels to facilitate document management and compliance objectives.
- Act as a centralized point of contact to support the Quality Intelligence process on behalf of Development Sciences.
- Learn new skills and contribute where needed within the Scientific Compliance team to support an “All for One AbbVie” approach.
- Adhere to codes of conduct and ethical principles and ensure compliance with applicable AbbVie policies and procedures.
- Utilize systems, documents, and tools to provide compliance support for centralized business function processes
- Support compliance and process improvement initiatives to enhance efficiency and compliance.
- Respond to unexpected occurrences and business needs.
- Identify and appropriately escalate potential compliance risks.
- Work in a highly team-based, cross-functional environment for daily activities/decision-making.
- With oversight, manage several tasks simultaneously.