The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance for cell and gene therapies. The Sr. Quality Specialist coordinates GMP activities in support of clinical Drug Product disposition. This position reports to the Director VCGT Operational Quality.
As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations at the VCGT facilities in the following key areas/activities: support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management
Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
Responsible for approval of COAs, generating BSE/TSE statement and product labelling
Responsible for archival of batch records and other supporting documents and for generating performance metrics for disposition
Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provide direction for product disposition decisions including shipment
Review and approval of Manufacturing documents as well as raw material release, area clearance, line clearance and equipment release
May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs
Provide QA support of change controls, GMP investigations and CAPAs. Responsible for generating performance metrics, trends
Participate in compliance walkthroughs and help drive the closure of any observations
Responsible for identifying risks and communicating gaps for GMP process/systems
Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
Participate in continuous improvements of department processes.
Participate in inspection readiness and support activities
Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner
Bachelor's degree in a scientific or allied health field with minimum 5-7 years of relevant work experience or Master's degree with 2-3 years of relevant work experience, or relevant comparable background.
Demonstrated success in independently leading cross-functional teams
Experience providing QA support and oversight of GMP manufacturing operations including batch release
Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
Cell and gene therapy cGMP's and associated CMC regulatory considerations
Experience successfully leading event investigations, Root Cause Analysis and CAPA
Experience with network based applications such as Oracle, TrackWise, Veeva