Quality Assurance Senior Manager

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

Purpose

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

• 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
• Bachelors Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering). Masters degree is highly desirable.
  
  
  

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 timeof this 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.
• This job is eligible to participate in our long-term incentiveprograms
  
  
  

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