IT Business Analyst (Quality Systems)
NovavaxFull time Full day
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
We are seeking a Business Analyst responsible for all aspects of computer systems related to Quality Assurance.
Responsibilities include but are not limited to:
- Clear understanding of the Quality Assurance business domain (such as QA documentation, quality systems, training, and compliance roles, functions, and processes), as it relates to technical solutions for Electornic Document, Quality, and Learning Management Systems (EDMS, QMS, LMS)
- Understands business needs; maintains awareness of industry trends; and provides recommendations to facilitate decision making
- Working knowledge of industry best practices and regulations relevant to assigned system(s)
- Gathers requirements from internal client(s)
- Consults with client(s) on new automated systems, providing guidance
- Helps to identify and evaluate systems and procedures for business solutions
- Works closely with the QA organization to: develop business cases; evaluate and qualify opportunities for business process and technology improvements, such as through cost benefit analysis; and provides insight for development of multi-year strategic roadmaps.
- Participates as an integral member of teams for system implementation projects of various complexities; may function as project manager for small projects
- Acts as technical liaison between client(s) and vendors to ensure technical solutions meet client needs and vendor stays on track
- Drafts technical documentation, test protocols, and procedures for assigned system(s)
- Working knowledge of change management
- Provides application support for validated applications; troubleshoots technical issues and manages problems through to resolution
- Bachelor or equivalent qualification level, or equivalent combination of education and experience is required
- 2-5 years of experience working with quality systems either in an IT or QA function, including proficiency in the use of electronic Document, Quality, and/or Learning Management Systems (EDMS, QMS, LMS).
- Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to quality assurance processes and procedures
- Experience with IT project management methodologies preferred.
- Ability to communicate effectively with all levels of the organization.
- An understanding of industry standards, systems development lifecycle, and change management methodologies
- Must posses: strong negotiation and collaboration skills; relationship management skills; customer service, analytical, critical thinking, and problem-solving skills; excellent verbal/written communication
Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
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