Quality Senior Manager

• Compensation: USD 124,500 - USD 236,500 - yearly

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  .

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Purpose

The Senior Manager, Quality provides leadership and direction for the Quality function within Operations. This role is responsible for the effective implementation of Abb Vie quality systems within their area of responsibility, including quality oversight of Abb Vie-owned warehouses (AP5, AP15, and AP32), the 3PL network, transportation service providers, and quality-relevant suppliers supporting distribution and logistics. Accountabilities also encompass training, regulatory compliance, quality planning, and strategic initiatives.

The Senior Manager, Quality leads a team of Quality professionals responsible for compliance and quality oversight across Abb Vie-owned warehouses, service providers, and strategic initiatives. This position manages a budget and is accountable for maintaining high product quality while driving operational efficiency.

Responsibilities:

• Oversee a team of Quality professionals responsible for quality assurance related to the distribution and logistics of products shipped from Abb Vie-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.

25% Travel*

• Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering;
  Master’s Degree or PhD preferred.
• Certified Quality Engineer or formal training in quality engineering or statistics is preferred
• 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
• 4+ years of supervisory/technical leadership experience
• Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
• Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates…