This role serves to provide leadership at the site Quality Operations level to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System. Quality excellence is a key strategic driver to ensure regulatory standards are understood and adhered to at the site operations level. This position holder will have responsibility for oversight of the Compliance and Regulatory activities for the site and ensure successful inspection outcomes and delivery of high quality, compliant products for the patients that we serve. 

Responsibilities

Oversight of Compliance and Regulatory activities at the site operations level, specifically leadership of a team responsible for a broad range of activities:

• Inspection readiness and execution for regulatory agencies; Audit readiness and execution for client audits
• Lead internal self-inspection program to maintain compliance with AbbVie quality requirements and global standards
• Support CMC filing and response to questions; provide data and support for market expansion filings
• Ownership of client quality agreements
• Ownership of risk management programs
• Facility related support such as pest control, engineering updates, and non-process related systems
• Ownership of the site management review program
• Leading and inspiring a team of individuals, providing an exceptional employee experience through clear communication, sensible goal setting, succession planning and development planning
• Demonstrating and Promoting AbbVie culture and Ways of Working
• Intention to be part of succession plan for Site Quality Director and open to possible opportunities in the broader AbbVie network