AbbVie

Supplier QA/Incoming Material QA Supervisor

Employer
AbbVie
Location
Worcester, MA, United States
Posted
Feb 21, 2021
Ref
2009497
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 .

  • Supervises a team of Analysts in the Quality function to include selection and hiring, setting performance expectations, performance assessment, train and staff development and resolution of personnel issues.
  • Responsible for supplier qualification and materials release.
  • Responsible for record reviews and materials release.
  • Provide Quality support on the manufacturing shop floor.
  • Delivery of files samples.
  • Complaint investigation and management.
  • Contract lab oversight including ER's, change requests and QTA.
  • Filing of GMP documentation.
  • Exception Request (ER) and CAPA management

Qualifications
  • 6+ years of direct experience in biopharmaceutical or related industry is required.
  • 2+ years of managerial experience preferred.
  • Thorough knowledge of Quality Assurance operations.
  • 6+ years of experience in application of FDA/GMP regulations.
  • Strong communication skills, tact, and diplomacy are critical.
  • Must be effective in multidisciplinary teams and work effectively across the organization.
  • Some direct manufacturing experience is preferred.
  • Direct regulatory interface experience is preferred.

Significant Work Activities
N/A
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.