QA Compliance and Regulatory Director
About AbbVieAbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 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. ResponsibilitiesOversight 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 auditsLead internal self-inspection program to maintain compliance with AbbVie quality requirements and global standardsSupport CMC filing and response to questions; provide data and support for market expansion filingsOwnership of client quality agreementsOwnership of risk management programsFacility related support such as pest control, engineering updates, and non-process related systemsOwnership of the site management review programLeading and inspiring a team of individuals, providing an exceptional employee experience through clear communication, sensible goal setting, succession planning and development planningDemonstrating and Promoting AbbVie culture and Ways of WorkingIntention to be part of succession plan for Site Quality Director and open to possible opportunities in the broader AbbVie network Bachelor’s degree is required; preferably in Engineering, Chemistry, Microbiology or Science related field15+ years’ experience in GMP pharmaceutical, biologics and/or medical device manufacturing; 5+ years of progressive people leading experience requiredLean Six Sigma Black Belt certification is preferredSkilled 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 industryAbility to manage multiple projects and work with global cross-functional teams.Experience in facilitation, negotiation, and influencing skills. Ability to drive change.Strong verbal...