Quality Control Manager

Allergan; Tempe, Northern (AZ, KY); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

Short-term incentive programs

Job summary

AbbVie in Tempe seeks a senior leader to manage laboratory operations across API/Finished Goods/Raw Materials and related QA initiatives. You will guide a large team of supervisors and analysts, ensure training, and align objectives with production and regulatory requirements.

You will interact with regulators (FDA/EU), develop budgets, and drive continuous improvement while maintaining compliance and meeting customer needs.

Qualifications

• Requires BS or MS in science with extensive relevant experience, or PhD with related experience.
• Strong technical lab operations expertise and understanding of regulatory requirements.
• Ability to work independently and manage complex research programs.
• Ability to design, execute, and manage budgets and personnel.

Responsibilities

• Lead a large team of lab supervisors and analysts; hire, develop, and manage staff.
• Ensure conformance to FDA/EU regulations; engage with regulators and customers.
• Manage budget and resources; align plans with Development, Manufacturing, and Customer needs.
• Conceive and execute research projects aligned with business strategy.
• Prepare project protocols, final reports, and support product registration needs.
• Negotiate timelines and costs for projects or contracts; maintain positive external relationships.

Skills

Technical lab operations

Product Quality

Quality Control Lab Operation

Regulatory requirements

Independent work

Research program management

Personnel management

Budget management

Internal/external customer interaction

Science and business understanding

Education

Bachelor's degree in Science or equivalent

Master's degree in Science or equivalent

PhD in Science or equivalent (preferred)

Job description

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/ negotiate with external contacts and customers to develop positive business relationships. Provides strategic direction for area of operation and ensures 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 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.

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

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

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminate.The amount and availability of any bonus,commission, incentive, benefits, or any other form of compensation 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.

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