QA Compliance and Regulatory Director

Abb Vie'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. For more information about Abb Vie, please visit us at

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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.

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 Abb Vie 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 Abb Vie culture and Ways of Working

Intention to be part of succession plan for Site Quality Director and open to possible opportunities in the broader Abb Vie network

Bachelor’s degree is required; preferably in Engineering, Chemistry, Microbiology or 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 medical device/bio/pharmaceutical 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 needed; excellent interpersonal skills required