Senior Manager, Product Quality

AbbVie - North Chicago, IL

Full-time - Mid Level

North Chicago, IL

Chemical Manufacturing

About the position

The Senior Manager, Product Quality at AbbVie is responsible for ensuring the quality of assigned products, which may include pharmaceuticals, biologics, combination products, and medical devices. This role focuses on meeting business objectives related to timely product delivery while ensuring compliance with local, divisional, and corporate policies, as well as external regulations. The position involves developing regulatory strategies in collaboration with Regulatory Affairs and managing quality assurance activities across various manufacturing sites.

Responsibilities

• Maintain primary quality lead with management oversight for project quality activities and team members to achieve on-time quality deliverables.
• Lead the development of global Product Quality Assurance strategy for pharmaceuticals, biologics, and combination products.
• Make key decisions on product quality and compliance issues, ensuring alignment of Quality and Technical Agreements with legal contracts.
• Establish and maintain relationships with Third Party Manufacturers and AbbVie plants to identify potential projects and issues.
• Communicate and negotiate with external companies' quality organizations to minimize compliance risks while balancing operational costs.
• Interface with Quality Assurance audit team to develop audit plans and maintain corrective action timetables.
• Manage Quality Assurance elements needed for new product launches and drive implementation of the Product Transfer Process.
• 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.

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, with direct Manufacturing Plant experience preferred.
• Comprehensive understanding of biological and/or pharmaceutical technologies including sterile and solid dosage forms.
• Strong background in quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation.

Nice-to-haves

• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with requirements for third party external manufacturing.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs