Location: Houston, Texas
Program: Vaccine Development
Reports to: Deputy Director, Sabin Vaccine Institute Product Development Partnership
The Manager, Quality Assurance will be responsible for establishing, implementing and ensuring the quality assurances, and interfacing with the regulatory requirements in our vaccine development initiatives.
This position will oversee the Quality Assurance team’s mission, ensuring that vaccines developed are of high quality and all related materials, processes and personnel comply with the requirements of relevant regulatory authorities. The Quality Assurance team may also play an advisory role for non-regulated research studies that may support downstream regulated vaccine development.
The Manager, Quality Assurance will collaborate closely with all functional units in the organization and work closely with our partners. He/she will coordinate the oversight and improvement of new and existing quality systems and databases. The individual must demonstrate the ability to handle multiple priorities and interface with individuals from various units, including manufacturing, vaccine product development, immunology laboratory, and regulatory, quality control, quality assurance, and clinical research. This individual will also help in defining programmatic milestones and assessing critical resources and timelines related to quality and/or regulatory concerns.
This is an exempt position reporting to the Deputy Director, Sabin Vaccine Institute Product Development Partnership.
Essential Duties and Responsibilities:
Core Quality Assurance Interests and Competences
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing
- Evaluate quality/regulatory risks of and recommend solutions to product and clinical safety issues during clinical phases
- Oversee development of department practices and policies and contribute to training of department/company on quality practices, policies and system
- Manage personnel training files, ensuring that required documents are up-to-date
- Design and support PDP personnel through the implementation of training workshops on GXP subjects
- Manage the tracking system for document control, inventory and release/stability testing and vendor audits
- Manage or conduct and assist with document, facility and procedural audits of contracted organizations to ensure compliance with domestic and international ethical and regulatory guidelines, as needed
- Provide support in the preparation and submission of quality/regulatory applications with the FDA, ANVISA and other regulatory authorities, including the review and compilation of CMC and other quality documents
- Participate in cross-functional teams to develop product development strategy for current and new vaccines; represent Quality Assurance at various CMC-related sub-team meetings
- Interact and collaborate with other functional units in the preparation, review, and assembling of the scientific (nonclinical, clinical and manufacturing) and administrative sections of submissions to reports and any regulatory document, as required
- Provide strategic input, technical guidance and advice as it relates to quality assurance topics
- Assist in the planning, organizing and conduct (or supervise) of formal meetings with contractors and other agencies
- Support the Deputy Director, Sabin Vaccine Institute Product Development Partnership, as needed
Quality/Product Development and Manufacturing Oversight
- Manage all site quality assurance operations to ensure that assessment of raw materials, packaging materials, in-process products and finished goods is performed consistent with cGMP, IND specifications and Sabin standards
- Serve as the primary quality assurance interface with product/clinical development team, ensuring the business needs for the product(s) are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all national and international regulatory requirements
- Manage and execute preapproval compliance activities
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
Leadership and Mentorship
- Provide mentorship and guidance to direct reports within Quality Assurance
- Hire, train and lead Quality Assurance staff, as needed
- Manage Quality Assurance staff to meet timelines and resolve issues
- Develop direct reports and work closely with them to ensure that a consistent approach is taken in evaluation and resolution of quality issues
Experience and Educational Requirements:
- Master’s degree or PhD in a scientific discipline, with a minimum of 7-10 years relevant experience required
- Previous industry experience in leading, developing, implementing and maintaining the activities of biopharmaceutical processes, Quality Assurance/Control, quality control systems, including Standard Operating Procedures and Policy guidelines
- Knowledge of FDA requirements (as appropriate)
- 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
- Ability to perform detail-oriented work with a high level of accuracy is a must
- Previous supervisory experience required
- Ability to travel (up to 10%) 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
- Excellent written, verbal and presentation skills
- Demonstrable experience in conflict resolution and consensus building
- Highly organized, approachable, flexible and the ability to respond to changes in a dynamic environment
- Extremely detail oriented
- Ability to prioritize work to meet deadlines
The Sabin Vaccine Institute (Sabin) is a non-profit, 501(c)(3) organization of scientists, researchers and advocates dedicated to reducing needless human suffering from vaccine-preventable and neglected tropical diseases (NTDs). Since its founding in 1993 in honor of Dr. Albert B. Sabin, the developer of the oral polio vaccine, Sabin has been at the forefront of global efforts to eliminate, prevent and cure infectious and neglected tropical diseases. Sabin develops new vaccines, advocates for increased use of existing vaccines and promotes expanded access to affordable medical treatments in collaboration with governments, academic institutions, scientists, medical professionals and other non-profit organizations. For more information please visit www.sabin.org.
The Sabin Vaccine Institute’s Vaccine Development program focuses on developing safe, effective and low-cost vaccines that can prevent human suffering caused by infectious and neglected tropical diseases. In 2000, Sabin established the Sabin Vaccine Institute Product Development Partnership (Sabin PDP). The Sabin PDP is an innovative model that relies on private, academic and public institutions in low- and middle-income countries, Australia, the United States and Europe to collaborate for preclinical development, vaccine manufacturing and clinical testing.
The Sabin PDP is the first and only vaccine development program targeting human hookworm infection. In addition, the Sabin PDP is developing vaccines for schistosomiasis, leishmaniasis, Chagas disease, ascariasis, trichuriasis and severe acute respiratory syndrome (SARS), diseases that primarily affect people living in poverty around the world. The product development laboratories are based at The Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine in Houston, Texas.
How to Apply:
To be considered, please submit your cover letter, resume and salary requirements via e-mail to firstname.lastname@example.org, fax to 202-842-7689 or mail to HR Manager, Sabin Vaccine Institute, 2000 Pennsylvania Avenue, NW, Suite 7100, Washington, DC 20006. Please be sure to reference “Manager, Quality Assurance” in the subject line. Your cover letter should: (1) address the reasons for your interest in this position; and, (2) describe the knowledge, skills and abilities you would bring to the Sabin Vaccine Institute and its Vaccine Development program. No phone calls, please. Only short-listed candidates will be contacted.
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.