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QA Process Transformation Lead

QA Process Transformation Lead

AbbVieKansas City, MO, US
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Process Transformation Lead

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

We are seeking a Process Transformation Lead to drive strategic initiatives in quality process optimization. This pivotal role entails partnering with both internal and external collaborators to streamline quality processes, delivering significant improvements in efficiency and compliance.

Key Responsibilities :

  • Develop and implement a strategic roadmap for quality transformation aligned with organizational objectives.
  • Drive the adoption of Lean, Six Sigma, and other Continuous Improvement (CI) methodologies across the quality organization.
  • Facilitate cultural change toward proactive quality management and problem prevention.
  • Manage and motivate employees using effective communication, coaching, and influencing skills.
  • Assist the Director of Site QA in managing resources and staff capacity aligned with business needs.
  • Ensure compliance with applicable AbbVie Quality and other policies and procedures.
  • Execute complex process improvement projects to enhance compliance and processing cycle times.
  • Lead strategy development for site contracting in compliance with quality policies and procedures.
  • Collaborate with the Quality and Training team for inspection preparation.
  • Assess the adequacy and effectiveness of the quality system through internal audits and quality assessments.
  • Analyze and report quality metrics to drive continual process improvements.
  • Provide expert advice to stakeholders to ensure compliance with AbbVie procedures and regulatory standards globally.
  • Manage and implement process improvement initiatives with quick turnaround expectations (60-90 days).
  • Mentor and coach team members in business process modeling, lean management, Six Sigma, and related disciplines.

Qualifications :

  • BA / BS degree required; MSc in a related discipline preferred (Business and / or Quality).
  • Lean Six Sigma Black Belt qualification preferred.
  • Minimum of 10 years of combined experience in the pharmaceutical industry, focusing on compliance management, quality assurance, and quality systems.
  • Proven track record in quality transformation and leading large-scale CI projects.
  • Strong knowledge of quality standards and expertise in Lean, Six Sigma, and other CI tools.
  • Excellent leadership, communication, and stakeholder management skills.
  • Experience working in a matrixed organization with cross-functional and cross-site teams.
  • Self-directed leader with strong business acumen and strategic direction-setting abilities.
  • Demonstrated advanced problem-solving skills, negotiation, and influencing capabilities.
  • Attention to detail and a solid understanding of the quality / compliance environment.
  • Ability to make informed decisions and recommendations in collaboration with the Quality Management Team.
  • AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

    US & Puerto Rico only - to learn more, visit abbvie.com / join-us / equal-employment-opportunity-employer.html

    US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more : abbvie.com / join-us / reasonable-accommodations.html

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