Quality Assurance Manager

  • Guilford, CT, USA
  • Full-time

Company Description

We are an AI-driven company with unique ability to match drugs to indications and prosecute through clinical development. AI Therapeutics’ revolutionary approach to drug discovery and development has advanced three drugs into clinical trials.

Job Description

We are looking for a Quality Assurance Manager to develop, implement and maintain the Quality Management System. Ensures internal and external quality compliance with stated practices and procedures and supports regulatory inspections and/or audits as necessary.

Responsibilities:

  • Coordinate with external contract organizations related to quality aspects of GxP activities
  • Develop, establish and maintain the internal quality management system
  • Lead for all document control processes related to quality systems, standard operating procedures, training and GxP   compliance requirements for the company
  • Ensure that quality practices are followed, including but not limited to, document control, design control, manufacturing control, clinical oversight and/or lab controls for projects, including facility, product, and/or CMO/CRO audits

Qualifications

  • Minimum 7 years in a QA leadership role within the pharmaceutical industry with knowledge in GMP, GLP and GCP and experience in small molecule and drug development lifecycle
  • Bachelor of Science or higher degree in a technical discipline
  • Experienced QA leadership background with a track record of establishing and maintaining quality systems
  • Ability and willingness to travel if required to fulfill responsibilities

Additional Information

We provide visa assistance for non­-U.S. applicants

Our competitive compensation plan includes salary, stock options and outstanding benefits.