Full Description

Overview: Job Description Summary: Provide leadership in formulating regulation policy including resource management and development, implementation, and maintenance of a Quality Management Program for the Phase 1/2A IND, Biologics and Good Tissue Practice programs. Lead quality input in process development IND manufacturing and quality control of biologics manufacturing program. Manage under the direction of the Director of Research Compliance & Integrity the implementation of quality management systems in relation to Quality Assurance in order to ensure product safety and regulatory compliance. Job Description: Essential Functions: Establish and maintain appropriate quality system to ensure compliance with regulatory requirements. Register, distribute and maintain controlled documents including but not limited to Quality Management Plan, Batch Record Documents, Standard Operating Procedures (SOPs), Master Validation Plans, Validation Protocols and Quality Assurance Manual. Represent the Biologics Manufacturing Facility during client and regulatory inspections. Represent the Research Institute (RI) during regulatory inspections. Ensure that requirements for quality systems are met according to FDA guidelines and industry standards for the manufacture of biologics and an overall program for Good Tissue Practices. Work closely with the Scientists, Biologics and Facility Management Teams for deviation investigations, process change controls and implementation of process improvement changes. Perform internal and external audits to ensure compliance with regulatory and internal guidelines. Provide cGMP training to staff on a continuing basis. Provide oversight to product development including raw material technical specifications and supplier selection. Approve and release product (investigational drug/device) for use in clinical trials and as appropriate to Good Tissue Practices. Assign and delegate responsibilities to Biologics QA Auditors. Develop and collaborate with Biologics Manufacturing Leadership on continuous improvement and CAPA projects. Education Requirement: Requires a MS degree in a scientific discipline or equivalent experience. Licensure Requirement: (not specified) Certifications: (not specified) Skills: Knowledge and expertise in the principles of current Good Manufacturing Practices. Strong technical documentation and auditing skills with the ability to work with complex details. Experience with cGMP practices relative to biological products and cell cultures. Experience: Minimum of five years of successful quality and regulatory experience. Physical Requirements: Note frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit. Sitting - Constantly Stooping - Occasionally Standing - Occasionally Talking on the phone or in person – Frequently Walking – Occasionally Additional Physical Requirements performed but not listed above: (not specified) "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet" The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose. Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. We’re 15,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere. Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere. Nationwide Children’s Hospital. A Place to Be Proud.