Description:
Responsible for overseeing and directing all aspects of quality assurance and compliance with applicable
regulatory requirements for media products. Develop and direct strategy for assuring compliance to
medical device and drug regulations. Individual should be self-directed and able to work independently
with general direction. The individual is expected to interact with Bioscience Media Operations
Management, Site leadership Team, QA and Operations leadership. Primary responsibility is Quality and
Compliance oversight of the aseptic processing of Bio therapeutic and Research media including those
classified as Medical Devices. Working knowledge and experience in aseptic drug product manufacturing
regulations and medical device quality management system regulations is required. Experience in quality
oversight of aseptic manufacturing.
At least 10 years of GMP experience in biologics manufacturing or equivalent
including at least 7 years management experience with at least 5 years in a QA
supervisory or management role. Working knowledge of cell culture starting
materials and aseptic processing experience required.
Experience with oversight of aseptic processing and the associated international
aseptic processing regulations and medical device regulations.
GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the
PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to
Good Manufacturing Practice Medicinal Products for Human and Veterinary Use,
including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485
and Part 11 compliance knowledge preferred. Working Knowledge of endotoxin
testing required.
Bachelor’s degree in life sciences required. Preferred area of study: Life Sciences