Research Operations Manager
About The Position
UNC’s Advanced Cellular Therapeutics Facility is looking for a qualified Research Operations Manager to join their team to help develop and maintain a Quality Systems program that will support the production of human cellular therapy and other manufactured drugs under Good Manufacturing Practices regulatory guidelines for patients receiving a multitude of therapies for the treatment of cancer and other diseases. The role will be responsible for the oversight of Quality Systems such as Batch Review and Release of products for distribution to patient, execution, review, and final approval of quality investigations, corrective action plans, change controls, validations, stability, document changes, vendor management, training of all employees, risk assessments, internal and external auditing, and lastly reporting of key performance indicators to management on status of Quality Management System operation. This role will manage Quality Systems employees to ensure all work is completed and supported. This role will ensure all employees are current on training requirements and has the knowledge necessary to execute their tasks. The role requires a person who understands Quality Systems in support of a cGMP Manufacturing Facility. This involves serving in leadership role regarding following and executing cGMP processes for all employees at the ACT Facility. The Research Operations Manager will work to ensure that the products meet all required quality standards, manage and execute the yearly audit schedule, manage the critical document control for the entire site, and ensure all material and equipment vendors are approved in accordance with site SOPs. This role will assist in the implementation and deployment of initiatives for the ACT facility. This role is expected to interact and coordinate activities/ projects with Facility and Operations Directors input to ensure projects align with facility goals. This role will work independently with little oversight and multi-task a number of ongoing activities. This role will be expected to make decisions on the execution of Quality processes. Additionally, the role must respond to facility issues quickly to have them resolved to not impact products for a patient.
Requirements
- Knowledge and experience in using Quality Systems in support of a cGMP Manufacturing Facility
- Two years of previous Quality experience
- Leadership experience and/or training in how to manage employees
- Excellent Word and Excel skills
- Ability to write and execute deviation investigations, CAPA, and complete system audits
- Ability to analyze data and information and report to management
- Ability to work with others to help them understand Quality Systems and how to execute them
Nice To Haves
- Prior experience working with transducing retrovirus for manufacturing human cellular therapy products
- Understanding cell culture processes and how Quality Systems are applied to them
Responsibilities
- Oversight of Quality Systems such as Batch Review and Release of products for distribution to patient
- Execution, review, and final approval of quality investigations, corrective action plans, change controls, validations, stability, document changes, vendor management, training of all employees, risk assessments, internal and external auditing
- Reporting of key performance indicators to management on status of Quality Management System operation
- Manage Quality Systems employees to ensure all work is completed and supported
- Ensure all employees are current on training requirements and has the knowledge necessary to execute their tasks
- Serve in a leadership role regarding following and executing cGMP processes for all employees at the ACT Facility
- Ensure that the products meet all required quality standards
- Manage and execute the yearly audit schedule
- Manage the critical document control for the entire site
- Ensure all material and equipment vendors are approved in accordance with site SOPs
- Assist in the implementation and deployment of initiatives for the ACT facility
- Interact and coordinate activities/ projects with Facility and Operations Directors input to ensure projects align with facility goals
- Work independently with little oversight and multi-task a number of ongoing activities
- Make decisions on the execution of Quality processes
- Respond to facility issues quickly to have them resolved to not impact products for a patient
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
