FLSA Status: Exempt
Original Date: 11/29/2016
Last Revision: 11/29/2016
JOB SUMMARY: The Manager, Quality Assurance conducts project related activities for the advancement of GMP / GTP and GLP-based work being conducted at the Wake Forest Institute for Regenerative Medicine. The Manager, Quality Assurance is the primary contact for document control, non-conformance investigations including CAPA systems, process and product mapping, internal and external auditing and batch record review and approval.
This position is an integral component of the Quality systems staff and will be responsible for working and receiving oral and/or written information from engineers, supervisors, managers and senior leadership. This position will be responsible for providing oral and written leadership of Quality department staff when requested.
- Responsible for day-to-day quality assurance activities for QC, Facilities, Manufacturing and GLP-based research.
- Oversees the development, implementation and maintenance of quality assurance systems and activities
- Oversees the development, implementation and follows procedures for review of inspection, testing and evaluation of clinical and process developmental products.
- Oversees the management of the shared drive information such as data, documents and project information.
- Writes, revises and reviews SOPs and all associated information to support internal systems, data systems, technical issues and instrumentation.
- Initiates and supports the deviation process in accordance to the SOPs.
- Oversees the development, implementation and maintenance of the quality training system and all training activities.
- Assures that products, processes, facilities and systems conform to quality standards and GLP / GMP regulations.
- Reviews and implements quality system changes to conform to applicable FDA Code of Federal Regulation sections.
- Provides assistance to other personnel regarding documentation of cGMP, cGTP and GLP-based technical issues.
- Ensures GMP and GLP-based regulatory compliance via partnership with Quality Control, Facilities, Manufacturing, Core Technician and Animal Care staff.
- Ensures GMP and GLP-based regulatory compliance via partnership with Quality Control, Facilities, Manufacturing, Core Technician and Animal Care staff
- Takes initiative to identify opportunities for process improvement implementation