Quality Control Manager

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Manages and provides strategic direction to laboratory business units consisting of one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/In-Process Laboratory Operations, Laboratory Support Operations, Laboratory Continuous Improvement/Compliance Operations and Microbial Environmental Controls.

• Manage a large team of lab supervisors and analysts. Is responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve personnel issues without direct supervision.
• Assure conformance to all government and corporate regulations. Responsible to develop, provide, defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators (FDA & EU) and customers to ensure no interruption in business due to compliance issues.
• Directs area of responsibility to meet production objectives within planned budgets. Provides input to management for resources needed to construct budget, updates, and changes in financial plan. Manages area supplies and equipment within budgeted amounts.
• Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
• Conceives, designs, conducts, and advanced independent scientific research activities per strategic business needs. Ensure research activities/projects are on track per business needs and established timeline.
• Develop, negotiate, finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customer’s needs.
• Conceives, design, and executes projects related to the strategic needs of the business operations.
• Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility.
• Applies advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs.
• Conducts business and interacts/ negotiate with external contacts and customers to develop positive business relationships. Provides strategic direction for area of operation and ensures tactical objectives are met.

• Required - BS degree in Science or equivalent + 8 years of relevant experience OR
  Master's degree in Science or equivalent + 6 years of relevant experience
  Preferred - PhD in Science or equivalent + 4 years of relevant experience.
• Must be experienced and demonstrate high level of technical skill in technical lab operations and good understanding of related business.
• Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required.
• Ability to work independently to meet operational goals and business needs.
• Ability to develop, design, execute and manage complex research programs.
• Ability to make operational and business decisions with minimum direction from immediate manager. Must have…