QC Manager Jobs in District Of Columbia

Job Title: Director of Quality Management Company: CST Medical Solutions Location: Washington, DC Description: Director of Quality Managementdf-lj

Job Title: Associate Director, Quality & Regulatory, Vaccine Development Company: Sabin Vaccine Institute Location: Washington, DC Description: Organization Summary:   The Sabin Vaccine Institute is a 501(c)(3) non-profit organization dedicated to reducing human suffering from infectious and neglected diseases. Through its efforts in vaccine research, development and advocacy, Sabin works to provide greater access to vaccines and essential medicines for millions mired in pain, poverty and despair. Founded in 1993 in honor of Dr. Albert B. Sabin, discoverer of the oral polio vaccine, the Sabin Vaccine Institute works with prestigious institutions, scientists, medical professionals, and organizations to provide short and long-term solutions that result in healthier individuals, families and communities around the globe. www.sabin.org.   Program Summary:   An essential element of the Sabin Vaccine Institute’s mission to reduce human suffering caused by infectious and neglected tropical diseases (NTDs) is our program in Vaccine Development conducted in collaboration with the George Washington University and other international organizations. In 2000, Sabin established an innovative non-profit Product Development Partnership (PDP) to develop recombinant vaccines for human hookworm infection and other NTDs, including schistosomiasis. Our Human Hookworm Vaccine Initiative is the first and only PDP with a mission to develop a vaccine to confer preventive immunity against human hookworm infection (‘hookworm’), an NTD that threatens vulnerable populations around the globe.   Headquartered in Washington, DC, Sabin’s Vaccine Development program has established a vaccine development pipeline that contains multiple antigens at various stages of development, each of which is being evaluated for potential formulation for clinical testing. Our vaccines are under clinical development in Brazil. The Sabin Vaccine Development program is pioneering the development of vaccines, which have no traditional commercial market. The diseases we combat represent the most common scourges of the world’s poorest people.   Position Summary:   The Associate Director, Regulatory and Quality is a senior management position and will be responsible for establishing, implementing and assuring quality and regulatory controls in our vaccine development initiatives. The Associate Director will collaborate closely with all departments in the organization and work closely with our partners. This is an exempt position, reporting to the Director of Vaccine Operations.   Essential Duties and Responsibilities:   Develop quality strategy and translate into tactical policies, processes and procedures to meet global regulatory, medical/health and legislative standards Oversee the development, implementation and maintenance of quality assurance systems and activities Direct the development and implementation of qualification and validation test procedures to ensure product(s) meet appropriate regulatory agency qualification and validation requirements, internal program standards and industry current practices Coordinate and prepare document packages for regulatory submissions, as well as internal audits and inspections Make recommendations for corrective action necessary to ensure conformity with quality specifications Ensure finished products conform to government and program standards and satisfy good manufacturing practices regulations Serve on functional and project oversight committees Conduct vendor audits Host regulatory audits   Experience and Educational Requirements:   A Master’s degree or PhD in a scientific discipline, with a minimum of 8-10 years relevant experience required Previous industry experience in developing, implementing and maintaining the activities of quality control systems, including Standard Operating Procedures and Policy guidelines for research and laboratory operations Previous experience with monitoring development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of biologic or vaccine products   Other Requirements:   Ability to travel – some travel may be required to partner sites, both domestically and internationally Expert knowledge of trends, techniques and best practices in vaccine development and clinical research Expert knowledge of applicable laws, regulations and professional standards as related to vaccine research and development Experience in researching and evaluating information, preparing concise, well-organized reports, summaries, correspondence, policy documents and personalized letters. Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package.   Sabin is an Equal Opportunity Employer. All persons shall have the opportunity to be considered for employment without regard to their race, color, religion, national origin, ancestry, age, disability or handicap, sex or gender, sexual orientation, marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.