Quality Assurance Lead

4 days ago


Morris Plains, New Jersey, United States Novartis Group Companies Full time
Job Overview

We are seeking a skilled Quality Assurance Lead to join our team at Novartis Group Companies.

About the Role

This position is responsible for ensuring compliance with regulatory requirements and maintaining high-quality analytical processes in the quality control department. The ideal candidate will have a strong background in quality assurance, excellent communication skills, and the ability to work effectively in a team environment.

Responsibilities
  • Coordinate and supervise the development, validation, and release testing of analytical methods and procedures.
  • Ensure adherence to cGMP, USP, and FDA guidelines, as well as company policies and procedures.
  • Collaborate with cross-functional teams to implement quality improvements and drive process efficiency.
  • Author, review, and approve quality documents, including protocols, reports, SOPs, and technical documents.
  • Investigate and resolve deviations, OOS/OOE/OOT issues, and CAPAs.
  • Lead audits and inspections, providing expertise on quality systems and processes.
Requirements
  • Bachelor's degree in a relevant science field (biology, chemistry, biochemistry, microbiology) and a minimum of 5 years of experience in analytical quality control or a related field.
  • Demonstrated knowledge of quality management systems, ICH, and FDA/EMEA GMP requirements.
  • Excellent communication, problem-solving, and leadership skills.
  • Ability to manage multiple tasks, prioritize projects, and meet deadlines.
What We Offer
  • A competitive salary range of $97,600 - $146,400 per year.
  • A comprehensive benefits package, including medical, dental, and vision coverage.
  • Generous paid time off, including vacation, sick leave, and parental leave.
  • Opportunities for professional growth and development.
  • A collaborative, inclusive work environment.
Location

The successful candidate will be based in Morris Plains, NJ, USA.



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