This position will join Cincinnati Children's Hospital's research administration, within the Office of Research Compliance and Regulatory Affairs, specifically providing regulatory support and quality assurance oversight to the Cincinnati Children's Hospital's Translational Core Labs Cell & Gene Therapy manufacturing operations to ensure compliance with FDA Good Manufacturing Practices and Good Tissue Practices. The Translational Core Labs manufactures products suitable for early phase clinical trials for both academic and pharmaceutical sponsors.
Regulatory Knowledge & Oversight
Independently interpret and analyze the concepts and principles of specific elements of federal and state law and institutional policies/procedures/guidance to ensure that all aspects of manufactured products, regulatory submissions (e.g. Drug Master File) and operational procedures are compliant with regulatory directives and assess the impact of specific regulatory decision on operations. Lead the creation and management of policies and procedures within assigned area.
Implements defined document control activities. Performs product release activities with minimal to no oversight. Write (as applicable), review and approve official documents, such as but not limited to executed batch records, validation protocols, deviations, Standard Operating Procedures, deviations, etc. related to the quality management system. Conducts internal and external audits, including vendor qualification audits, develops reports and evaluates corrective actions. Design and lead risk assessments related to manufacturing and testing activities, and document outcomes. Consistently interacts with manufacturing/operations personnel as needed, including interactions with external stakeholders. Identifies and leads the quality improvement activities and may be accountable for achieving defined outcomes.
Teamwork, Collaboration & Leadership/Management
Work collaboratively with diverse teams and interface effectively with primarily internal and occasionally external stakeholders across the organization. Build consensus among stakeholders, based on priorities established by more senior leadership, gaining commitment to achieve defined institutional priorities, while ensuring that the organization is adhering to required regulatory standards. Use basic project management and organizational skills to lead divisional/departmental initiatives. May lead the development and execution of specific aspects of the quality management system in support of the institution's research strategic plan. Contribute to recommendations for solutions that maximize organizational performance. Represent CCHMC at the regional and national level disseminating best practices.
Training & Development
Train personnel on Standard Operating Procedures and FDA regulations. Ensure that provided training meets required standards. Act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management.
Required for Specialist-GxP QA:
Bachelor's degree in a related field
2-5 years of work experience in a related job discipline
Required for Sr. Specialist-GxP QA:
Bachelor's degree in a related field
5-7 years of work experience in a related job discipline OR Master's degree and 3 years of work experience in a related job discipline.
Applicable professional certification required within 24 months for outside hire.
Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).
About Cincinnati Children's Hospital Medical Center
At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better, and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.