Manager, Quality Assurance III

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.

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

To provide strategy for Quality staff by managing daily activities with consideration to the LRP. Strong decision making and communication for issue resolution within the Quality System.

Responsibilities:

• Responsible for ongoing compliance with and understanding of applicable policies and procedures, including cGMP
• Defines strategy for staff to manage daily activities for planning and implementing the LRP.  
• Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant.
• Quality oversight of drug product manufacturing and finished good packaging, as well as batch record review and batch release. 
• Supports internal and external audits, providing responses and developing improvement plans
• Provides an active role in implementation of policy and procedure in support of the Quality System for the plant. Reviews and approves Quality system documents and records
• Member of the change review board, reviewing and approving validation documents and change controls
• Provides feedback and approves non-conformances and deviations, identifying improvements and responding to trends

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• 8+ years of direct experience in biopharmaceuticals or related industry
• 4+ years of managerial experience
• Demonstrated knowledge of Quality Assurance Operations
• 8+ years of experience in application of FDA/GMP regulations
• Strong communication skills, tact and diplomacy
• Demonstrated effectiveness in multi-disciplinary teams across the organization
• Ability to represent Quality function effectively with senior management and external parties
• Direct manufacturing experience is strongly preferred
• Direct regulatory interface experience is preferred
• Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering). Master’s degree is highly desirable.

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

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• 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 short-term incentive programs. ​

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

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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. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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