Associate Director, Quality Control Laboratory

AbbVie; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie seeks a seasoned head of laboratory operations to lead QC Laboratory teams across API, Finished Goods, Raw Material/In-Process areas. You will manage Managers, Supervisors and Analysts, ensure regulatory compliance, and drive continuous improvement within budget.

The role requires strong technical lab expertise, strategic planning, and collaboration with regulators and customers to avoid business interruptions.

Qualifications

• BS degree in Science or equivalent with 10+ years of relevant experience, or MS with 8+ years; PhD with 6+ years preferred.
• Strong technical skill in technical lab operations and understanding of related business.
• Knowledge of Product Quality, Quality Control Lab Operation and Regulatory requirements.

Responsibilities

• Manage a team of Managers, Supervisors and Lab Analysts; hire, lead and develop staff to meet business objectives.
• Ensure conformance to government and corporate regulations; meet with regulators (FDA & EU) and customers to prevent compliance issues.
• Direct area of responsibility to meet production objectives within budgets; provide input to resources and budget planning.
• Establish and execute plans and commitments aligned to Development, Manufacturing, Customers and Business needs.
• Conceive, design, and conduct advanced independent scientific research per strategic business needs.
• Develop, negotiate, and finalize timelines and cost estimates for projects and/or service contracts.
• Conceive, design, and execute projects related to strategic business needs.
• Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods and QA training.
• Apply advanced technical writing to prepare project protocols and final reports for product registration or business needs.
• Interact with external contacts and customers to build positive business relationships.

Skills

Team leadership

Regulatory knowledge

Budgeting

Lab operations

Project management

Technical writing

Education

BS in Science or equivalent

MS in Science or equivalent

PhD in Science or equivalent

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Will typically serve as the head of the laboratory operations for the plant. Responsible for management of the QC Laboratory organization which may include management of Managers, Supervisors and Analysts. Manages a business unit consisting of one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, and Laboratory Continuous Improvement/Compliance Operations.

Responsibilities

• Manage a team of Managers, Supervisors and Lab 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 people 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 manager 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/ negotiates with external contacts and customers to develop positive business relationships.

Qualifications

• Required - BS degree in Science or equivalent and 10+ years of relevant experience OR Master's degree in Science or equivalent and 8+ years of relevant experience Preferred - PhD in Science or equivalent and 6+ 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.

Additional Information

• The compensation range described below 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 this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.


• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.


• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html