Quality Control Leader — Lab Operations & Compliance

SmartRecruiters, Inc.; Tempe (AZ); On-site; USD 110,000 - 209,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Short-term incentives

Job summary

AbbVie seeks a senior leader to manage laboratory operations across API, Finished Goods, Raw Materials, and related support areas. You will hire and develop staff, ensure regulatory compliance, and drive projects within budget and schedule.

The role requires directing large teams, coordinating with regulators and customers, and delivering on strategic research and cost estimates for contracts to support business needs.

Qualifications

• Required - BS degree in Science or equivalent + 8 years of relevant experience
• 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 knowledge and skill in personnel management, and develop and managing budget.
• Ability to interact and establish positive interaction with internal/external customers.
• Shows broad understanding of the issues relevant to technical/science and business.

Responsibilities

• Manage a large team of lab supervisors and analysts. Is responsible to hire, lead and develop team members to ensure the department has the appropriate talent and level of performance to meet business objectives.
• 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.
• 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.
• 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/ negotiates with external contacts and customers to develop positive business relationships.

Education

BS degree in Science or equivalent

Master's degree in Science or equivalent

PhD in Science or equivalent

Job description

AbbVie seeks a senior leader to manage laboratory operations across API, Finished Goods, Raw Materials, and related support areas. You will hire and develop staff, ensure regulatory compliance, and drive projects within budget and schedule.

The role requires directing large teams, coordinating with regulators and customers, and delivering on strategic research and cost estimates for contracts to support business needs.