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AbbVie - North Chicago, IL

posted about 2 months ago

Full-time - Senior
North Chicago, IL
Chemical Manufacturing

About the position

The Senior Product Quality Manager is responsible for ensuring the quality of assigned products, including pharmaceuticals, biologics, and medical devices, while meeting business objectives and compliance with regulations. This role involves leading quality assurance strategies, managing relationships with third-party manufacturers, and overseeing quality activities to ensure timely delivery and regulatory compliance.

Responsibilities

  • Maintain primary quality lead with management oversight for project quality activities and team members.
  • Lead the development of global Product Quality Assurance strategy for pharmaceuticals, biologics, and combination products.
  • Make key decisions on product quality and compliance issues, elevating medium and high-risk events to management.
  • Establish and maintain relationships with Third Party Manufacturers and AbbVie plants to identify projects and issues.
  • Communicate and negotiate with external companies' quality organizations to minimize compliance risks.
  • Interface with Quality Assurance audit team to develop audit plans and maintain corrective action timetables.
  • Manage Quality Assurance elements for new product launches and facilitate the Product Transfer Process from R&D to AbbVie sites.
  • Support the management of exception documents and Corrective and Preventive Actions.
  • Develop product quality transfer process monitoring metrics and manage small teams of quality professionals.
  • Support regulatory filings and marketing authorization dossiers.

Requirements

  • Bachelor's Degree in relevant Life Science, Engineering, or other technical discipline required.
  • Minimum 8+ years of total combined experience, with at least 3 years in Quality Assurance Operations Management.
  • 5+ years in Operations, Research and Development, Regulatory or Consulting.
  • Direct Manufacturing Plant experience in an Aseptic Pharmaceutical setting is preferred.
  • Comprehensive understanding of biological and/or pharmaceutical technologies.
  • Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background required.
  • Experience with FDA and other regulatory agency interactions and inspections is required.

Nice-to-haves

  • Familiarity with the requirements for third party external manufacturing.
  • Possesses strong analytical and problem-solving skills.
  • Ability to manage multiple complex tasks simultaneously.

Benefits

  • Health insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Professional development opportunities
  • Flexible scheduling options
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