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Quality Assurance Project Manager

Employer
AbbVie
Location
Lake County, IL, US
Start date
Nov 15, 2019

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Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

  • Ensure accurate integration and support of quality regulations: drug, biologics, device and/or combination products.
  • Lead project teams in planning, preparation, review and approval of quality documentation for Elemental Impurities Program.
  • Responsible for implementing and maintaining the efficiency of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.
  • Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
  • Lead all aspects of the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
  • Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
  • Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
  • Interact with internal and external partners for development of standard methodologies in our quality systems and procedures.
  • Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
  • Coordinate the implementation and management of training and education programs for various aspects of quality assurance.


  • Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
  • 8+ years' experience in quality assurance, quality oversight or relevant experience.
  • Leadership of technical professionals and in leading cross-functional teams.
  • Technical knowledge in as many of the following areas: Quality, Regulatory, Process Sciences, Manufacturing Operations.
  • Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
  • Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
  • Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
  • Strong oral (with all levels of management) and written communication skills needed.
  • Excellent interpersonal skills a plus.
  • Can lead medium to larger projects with a growing level of complexity and size to deliver tactical results that support strategic initiatives.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
 North Chicago
Illinois
60064
US
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