AbbVie

Manager, Quality Assurance

Employer
AbbVie
Location
Lake County, Illinois
Posted
Nov 22, 2021
Ref
2119572
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • 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. Evaluates and develops tools to enable staff to continually improve performance and maximize productivity
  • 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
  • Leads or participates in strategic initiatives to improve the following when possible:-Batch record review and release-VCRs and validation protocols-Lot disposition and/or finished goods and/or commodities-APRs/PQRs-Quality metrics-Track and trend activities-Change management-Risk management-Training-Data integrity
  • Performs in-process testing to support Quality on the manufacturing floor
  • Provides feedback and oversight for complaints, non-conformances and deviations, identifying improvements and responding to trends
  • TPM and TPC Quality management, including exception requests (ERs),change requests (CRs) and QTA
  • Reviews and approves Quality system documents and records
  • Tests commodities and raw materials for product compliance and manages retained samples

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

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.