Senior Quality Manager, GMP and Logistics

Regulatory Toolkit; Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Manager, Quality to lead quality oversight for distribution and logistics across AbbVie-owned facilities and 3PLs. You will guide regulatory compliance, quality systems, and training in support of cGMP and FDA requirements.

You will manage a team of quality professionals, administer budgets, and partner with leadership on quality initiatives and issue resolution. Travel is expected up to 25%.

Responsibilities

• Oversee a team of Quality professionals responsible for quality assurance related to the distribution and logistics of products shipped from AbbVie-owned facilities and third-party logistics providers.
• Provide quality and regulatory compliance leadership for complex operations with high volume and product complexity, including biologics, medical devices, CRT, cold chain, and frozen products.
• Serve as the decision-making authority for job-specific aspects of the quality and regulatory compliance program across assigned sites.
• Ensure quality metrics and key performance indicators are aligned with corporate quality requirements and applicable regulatory requirements.
• Manage, organize, train, and supervise the Quality team to ensure effective functional performance.
• Provide regulatory and technical guidance to required departments and serve as a subject matter expert as needed.
• Communicate with leadership regarding quality management reviews, quality initiatives, and issue resolution.
• Develop and administer the annual operating budget for the Quality unit.
• Make quality decisions related to all aspects of distribution and logistics — including change management, process management, quality systems, and management review — to ensure compliance with cGMP, FDA, EU, DEA, and other applicable regulatory requirements.

Job description

AbbVie is seeking a Senior Manager, Quality to lead quality oversight for distribution and logistics across AbbVie-owned facilities and 3PLs. You will guide regulatory compliance, quality systems, and training in support of cGMP and FDA requirements.

You will manage a team of quality professionals, administer budgets, and partner with leadership on quality initiatives and issue resolution. Travel is expected up to 25%.