Quality Control Manager

Regulatory Jobs; Tempe (AZ); On-site; USD 130,000 - 185,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks an experienced leader to manage laboratory operations across multiple disciplines, ensuring regulatory compliance and strategic direction for projects and contracts. You will oversee a large team of supervisors and analysts, driving quality and efficiency while aligning with budgetary goals and business needs.

The role requires deep technical expertise in lab operations, knowledge of quality systems, and strong communication with regulators and external customers.

Qualifications

• BS degree in Science or equivalent with 8 years relevant experience; MS with 6 years; PhD with 4 years preferred.
• Extensive technical skill in laboratory operations and strong business understanding.
• Knowledge of Product Quality, Quality Control Lab Operation and Regulatory requirements.
• Ability to work independently to meet operational goals and budgets.

Responsibilities

• Manage a large team of lab supervisors and analysts and develop staff.
• Ensure conformance to regulations and engage with regulators and customers when needed.
• Direct area to meet production objectives within budgets and manage resources.
• Plan, commit to timelines, and execute projects aligned with business needs.
• Conduct and oversee independent scientific research activities per strategy.
• Prepare timelines and cost estimates for projects or service contracts.

Skills

Technical lab operations

Regulatory requirements

Product Quality

Quality Control Lab Operation

Budget management

Personnel management

External customer interaction

Independent work

Education

BS degree in Science

MS degree in Science

PhD in Science

Job description

About AbbVie

AbbVie'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, visit www.abbvie.com.

Purpose

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.

Responsibilities

• Manage a large team of lab supervisors and analysts. Hire, lead and develop team members to ensure the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates, assist in problem solving, and identify and resolve personnel issues without direct supervision.
• Assure conformance to all government and corporate regulations. Develop, provide, defend and 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.
• Direct area of responsibility to meet production objectives within planned budgets. Provide input to management for resources needed to construct budget, updates, and changes in financial plan. Manage area supplies and equipment within budgeted amounts.
• Establish and execute plans and commitments consistent with Development, Manufacturing, Customers and Business needs.
• Conceive, design, conduct and advance independent scientific research activities per strategic business needs; ensure projects are on track per established timelines.
• Develop, negotiate and finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customers' needs.
• Conceive, design and execute 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.
• Apply advanced technical writing skills to prepare project protocols and final reports to support product registration and/or business needs.
• Conduct business and interact/negotiate with external contacts and customers to develop positive business relationships. Provide strategic direction for area of operation and ensure tactical objectives are met.

Qualifications

• 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 a 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 in developing and managing budgets.
• Ability to interact and establish positive interaction with internal/external customers.
• Shows broad understanding of the issues relevant to technical/science and business.

Compensation & Benefits

• The compensation range is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation will depend on many factors including geographic location.
• Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. Learn more: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. Reasonable accommodations: https://www.abbvie.com/join-us/reasonable-accommodations.html