Manager, Qa

Job Description
Purpose
Quality Assurance and Inspection Management is responsible for directing, implementing, training and providing consultation for external manufacturing/packaging worldwide. To assure compliance with global regulatory requirements.
Responsibilities
Manage GxP quality/inspection activities to assure that quality system, manufacturing facilities, testing programs, clinical and pre-clinical study conduct, personnel and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations.
Influence and train inspection preparation teams comprised of a variety of technical experts.
Coordinate GxP pre-approval inspection preparation activities for contract facilities utilized in support of regulatory filings.
Strategize corrective action plans and provide compliance support during implementation to ensure GMP compliance andsuccessful inspections.
Effectively communicate risks to management, both orally and in writing.
Quality Systems:
Provide guidance and interpretation of QA Policies and Procedures based on applicable requirements/regulations. Management of the external contract facilities against GxP.
In some U.S. manufacturing sites, performs batch release.