Quality Control Manager

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

• Compensation: USD 109,500 - USD 208,500 - yearly

Company Description

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 about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

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. 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/ negotiates with external contacts and customers to develop positive business relationships. Provides strategic direction for area of operation and ensures tactical objectives are met.

Qualifications

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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• paid time off (vacation, holidays, sick)


• medical/dental/vision insurance


• 401(k) to eligible employees


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

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable 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.

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