Research Operations Manager

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research.

Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.

Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.

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.

Bachelor's degree and two years of general research experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Requires knowledge and experience in using Quality Systems in support of a cGMP Manufacturing Facility. Two years of previous Quality experience is necessary. Has leadership experience and or training in how to manage employees. Has 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.

Prior experience working with transducing retrovirus for manufacturing human cellular therapy products is highly desired. Understanding cell culture processes and how Quality Systems are applied to them is a bonus

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.