The Quality Systems Manager is responsible for the management of the quality systems elements of clinical and commercial drug substance and final product contract manufacturing systems and their interaction with company's quality system.
The Quality Systems Manager is also required to support the company commercial launch preparation efforts with “hands on” service for quality, regulatory or other teams as required.
Provide structure and continued improvement to the Pharmaceutical Quality System.
Interact with contract manufacturing representative on quality systems issues.
Lead efforts to gather accurate information to annual product reviews.
Qualify or re-qualify suppliers via audits and review of historical regulatory and compliance histories, or supplier questionnaires.
Respond to product complaints by interacting as necessary with US and EU pharmacovigilance vendors.
Attend meetings with vendors and teams to represent quality and/ or regulatory needs.
Negotiate with contact manufacturing and testing organizations to resolve quality issues.
Represent Quality as a quality subject matter expert during regulatory inspections.
Writing and or approving standard operating procedures or other controlled documents to enhance the Pharmaceutical Quality System.
Development and maintenance of a robust document management system.