Principal Quality Leader

Job Summary

Seeking a highly motivated Principal Quality Leader to work remotely in a full-time capacity, responsible for providing technical expertise and leadership within the Product Quality Team, engaging with various departments on product filings, program improvements, and investigations related to product manufacturing and quality control.

Key responsibilities

• Provide cross-functional quality leadership and support for late phase and commercial programs, ensuring compliance with annual product reviews and regulatory filings
• Support the evaluation of complex process and product quality data, developing patient-oriented strategies and solutions
• Manage Product Quality related activities, including authoring and reviewing GMP and regulatory documents, and executing transactions in relevant GMP systems

Required qualifications

• Doctorate degree with 2 years or Master's degree with 4 years or Bachelor's degree with 6 years or Associate's degree with 10 years or High School Diploma/GED with 12 years of relevant experience in Quality, Operations, Scientific, or Manufacturing
• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
• 6+ years of experience in a regulated environment with biologic products
• 1+ year experience with authoring or reviewing market applications or similar regulatory documentation
• Proficiency in knowledge of cGMP and international regulatory expectations