Organization: Sabin Vaccine Institute
Location: Houston, Texas
Program: Vaccine Development
Position Title: Program Officer, Quality Assurance
Reports to: Deputy Director, Sabin Vaccine Institute Product Development Partnership
The Program Officer, Quality Assurance, Vaccine Development will be responsible for quality assurance functions. This individual will work closely with other team members from the quality assurance and regulatory units to achieve the Quality Assurance team’s overall mission, ensuring that vaccines developed are of high quality and all related materials, processes and personnel comply with the requirements. The incumbent will also have an advisory role for any non-regulated research studies that support Sabin PDP projects.
The Program Officer’s tasks will primarily be focused in pre-clinical and clinical vaccine development activities, and will include the oversight and improvement of new and existing documentation systems and databases. The individual will review, revise and create, as needed, protocols, quality agreements and standard operating procedures (SOPs) to meet the requirements of Sabin’s Core Quality System. This individual must demonstrate the ability to handle multiple priorities and interface with individuals from cross-functional areas of the PDP and external contractors and vendors. This individual will also review and compile materials for technical transfers and CMC sections. The Program Officer will help in defining programmatic milestones and assessing critical resources and timelines related to quality concerns.
This is an exempt position reporting to the Deputy Director, Sabin Vaccine Institute Product Development Partnership.
Essential Duties and Responsibilities:
- Develop, write, update and revise SOPs as necessary
- Support laboratory personnel through the implementation of training workshops on subjects such as cGMP and GLP
- Review and approve quality agreements, laboratory protocols and records for the performance of formal testing at PDP and external facilities as related to compliance with GXPs
- Conduct data, systems and in-process audits
- Assist in development and maintenance of document archives
- Track release and stability testing of regulated products
- Monitor system for vendor audits to initiate audits once period established has expired
- Conduct and assist with document, facility and procedural audits of contracted organizations to ensure compliance with regulatory guidelines
- Provide support in the preparation and submission of regulatory applications with the FDA, ANVISA and other international regulatory authorities, including the review and compilation of CMC and other quality documents
- Support the Quality Assurance and Regulatory Managers, Project Managers, or designees, as needed
- Assist Sabin PDP Deputy Director in maintaining and implementing the Sabin Quality System Unit
- Other duties as assigned by the Sabin PDP Deputy Director
Experience and Educational Requirements:
- A Bachelor’s or Master’s Degree in a relevant scientific discipline
- A minimum of 3-5 years of experience in the pharmaceutical industry in Quality Assurance/Control, Manufacturing or Process/Analytical Development
- Knowledge of FDA requirements (as appropriate)
- Ability to perform complex statistical analysis
- Experience developing and reviewing SOPs, protocols, batch records and testing records
- Excellent written and oral communication skills
- Ability to perform detail-oriented work with a high level of accuracy
- Ability to accept supervision and work effectively in challenging situations
- Ability to critically review data to identify concerns
- Ability to travel up to 10% of the time required
- Must be extremely resourceful and able to work independently, with limited supervision, in managing the diverse needs of the Vaccine Development QA program
- Must be able to prioritize work to meet deadlines and multi-task; handle and resolve challenges effectively and efficiently
- Excellent written and oral communication skills
- Ability to multitask, problem solve, set and meet deadlines
- Ability to work collaboratively with all levels of staff and range of personalities, culture and working styles
- Excellent project management and organizational skills
- Ability to perform detail‐oriented work with a high level of accuracy
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 email@example.com, 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 “VD PO QA TX” 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.