QA Compliance and Regulatory Director

About the Company

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.

About the Role

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. The 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 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

Qualifications

• Bachelor’s degree is required; preferably in Engineering, Chemistry, Microbiology, or a Science-related field
• 15+ years’ experience in GMP pharmaceutical, biologics, and/or medical device manufacturing; 5+ years of progressive people-leading experience required
• Lean Six Sigma Black Belt certification is preferred
• Skilled in strategy development, initiation, selection, coordination, and management of projects and have the ability to solve unique problems
• Advanced knowledge of cGMPs, GXP, and other regulatory standards and guidelines applicable to the medical device/biopharmaceutical industry
• Ability to manage multiple projects and work with global cross-functional teams
• Experience in facilitation, negotiation, and influencing skills; ability to drive change
• Strong verbal and written communication skills; excellent interpersonal skills required

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Medical, dental, and vision insurance
• 401(k) to eligible employees
• Eligibility to participate in long-term incentive programs