Provide Technical and Quality Assurance expertise to all GXP functions (GCP, GLP, GMP). Manages supplier qualification, quality documentation systems including but not limited to batch release, change control, deviation and product complaint systems. Support clinical research, development and manufacturing activities and related projects to ensure regulatory complaint, robust and consistent manufacturing, testing and clinical development processes.
A minimum of seven years pharmaceutical experience with at least five years of experience in Quality or Regulatory Compliance Operations in the pharmaceutical industry in a decision making capacity.
General knowledge and understanding of the clinical development lifecycle.
General knowledge of GXP quality systems required for development and commercial biopharmaceutical organizations.
Experience in supporting quality and compliance for Phase I-III clinical and commercial operations.
Experience working with third party contract research, development, manufacturing and/or testing organizations.
Experience with resolving complex quality and CMO issues, as well as corrective and preventive actions identification to resolve non-conformances/trends.
Standard operating procedures along with controlled changes updates and implementation of actions driving Quality Management System compliance with regulations.
Bachelor’s degree in a scientific discipline required.
ASQ, ACRP, or RAPS certification preferred.
Ability to be on call before and after core business hours.
Ability to travel domestic and internationally ≤ 20%.