Senior, Quality Associate II, Regulatory Affairs/Quality Assurance

Worcester, Massachusetts
Apr 02, 2021
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Description - External

  • Review technical reports and submission relevant documents. Format and publish documents in relevant database.
  • Coordinate update of drug master file, site master file, annual product review reports and submission relevant documents as requested by clients and internal regulatory submission team
  • Represents department and participates in meetings with cross functional teams
  • Broadly applies regulatory/technical knowledge of corporate and government regulations and skills across therapeutic areas.
  • Effectively presents pertinent information to appropriate cross-functional groups. Effectively delivers difficult messages to commercial organization while maintaining a positive and effective relationship
  • Establishes solid relationships with management and key stakeholders fostering mutually beneficial interactions and exchange.
  • Demonstrates excellent communications, negotiation skills, problem solving skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.


Qualifications - External

  • Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related
  • Required Experience: 3-4 years Quality Assurance/Regulatory, R&D or pharmaceutical industry related experience
  • Experience working in a complex and matrix environment


Significant Work Activities
Yes, 5 % of the Time
Job Type
Job Level Code
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.