Manager, Business Analysis for Quality Systems

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Job Summary

Novavax Information Technology seeks a Manager of Business Analysis for Quality Systems responsible for all aspects of computer systems related to Quality Assurance. This position leads a team of Business Analysts (BAs), System Engineers, and managed services contractors, serving as a managerial and functional resource and subject matter expert for Quality systems. The position reports to the Senior Director of Business Technology for Quality and Regulatory systems.

Essential Functions

• Participates as a leader and an integral member of teams for system implementation projects of various complexities; may function as project manager for small projects.
• 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 Electronic Quality Management Systems (QMS).
• 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 colleague(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.
• Lead and manage documentation of processes, common resolutions/solutions, and application support processes to augment knowledge gaps.
• Guides or drafts technical documentation, test protocols, and procedures for assigned system(s).
• Detailed knowledge of change management.

Supervisory Responsibilities

• Leads a team of Business Analysts who act as technical liaisons between internal business colleague(s) and vendors to ensure technical solutions meet Novavax requirements.
• Coordinates application support for validated applications; troubleshoots technical issues and manages problems through to resolution.

Required Knowledge, Skills, and Abilities

• Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to quality assurance processes and procedures.
• Demonstrated ability to lead cross-functional teams within IT and with other business groups.
• Ability to communicate effectively with all levels of the organization.
• An understanding of industry standards, systems development lifecycle, and change management methodologies.
• Must possess strong negotiation and collaboration skills; leadership skills; relationship management skills; customer service, analytical, critical thinking, and problem-solving skills; excellent verbal/written communication.
• Good business and technical acumen to understand the value of business capabilities enabled by IT.
• Good presentation, communication, facilitation, and influence skills; understanding of organizational change management concepts.

Education, Experience, Licenses & Certifications (align with knowledge, skills, and abilities)

• 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 Quality Management Systems (QMS).

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.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.