Quality Laboratory Manager

Purpose
The Quality Laboratory Manager will ensure quality control and quality assurance compliance across our Waco Texas manufacturing site and serve as an integral member of the site leadership team. This role will have a large focus on ensuring quality system requirements are achieved as well as lead the site quality control unit and serve as primary backup to the QC Site Director.

This role manages and provides strategic direction to laboratory business units consisting of: Finished Goods Laboratory Operations Raw Material/InProcess Laboratory Operations and Laboratory Continuous Improvement/Compliance Operations. 

Responsibilities

• Manage a large team of lab supervisors and analysts. 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.
• Responsible for meeting 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 to Development Manufacturing Customers and Business needs.
• Conceive design conduct and advance 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 customers needs.
• Conceive design and execute projects related to the strategic needs of the business operations.
• Provide timely testing or of inprocess 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 protocol and final reports to support product registration and/or business needs.
• Coordinate and manage communication/negotiation with external contacts and customers to develop and foster positive business relationships. Provide strategic direction for area of operation and ensure tactical objectives are met.

Qualifications :

• Bachelors degree in Science is required 8 years of relevant experience OR Masters degree in Science 6 years of relevant experience. Preferred PhD in Science 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 or local law: 

• 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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No