Associate Specialist, Scientific Compliance

Compliance Liaison

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.

Qualifications

• Minimum of Associate's degree (scientific field preferred).
• Typically 3 (Associate's), or 0-2 (Bachelor's) years of industry related (i.e. GxP) experience.
• Experience with document management processing is preferred.
• Familiarity with various software applications such as Microsoft platform (i.e., SharePoint, OneNote, Word, Excel, etc.), Veeva Vault, Salesforce (AbbVie OneTrack), etc. is preferred
• Basic understanding of R&D drug development/medical device processes preferred.
• Good interpersonal skills with ability to effectively communicate in a clear manner; proficient in business/technical communications.
• Good organizational and time management skills.
• Strong attention to detail.
• Works well in a fast-paced global team environment

Pay Range:

$ 58656 - 110500 USD