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. Summary of the Position :
The Senior Manager of QMO is responsible for internal and external QM Activities to support CQA program and quality systems for compliance to Novavax SOPs and all relevant regulations, guidelines, and industrial best practices. Core Functions :
Core Skills :
- Develops, implements, and maintains policies, systems, procedures, and tools for CQA audit management of quality and compliance with applicable regulations and guidelines that ensure sustained compliance with GCP, GVP, GLP and GCLP standards.
- Develop, implement, and execute the GCP, GVP, GLP and GCLP audit strategy and plan using risk-based approach and a Global Audit Master Schedule for all audit types
- Develop and Manage new GCP vendor qualifications and existing vendor re-qualification
- Monitor and manage GCP, GPV, GLP and GCLP findings, deviations/Quality Events and CAPAs timeliness and effectiveness checks
- Identify and follow-up on any unresolved audit findings identified in a CQA Audit
- Support CQA Regulatory health authority inspections activities and the development of corrective actions for findings from such inspections
- Manage regulatory intelligence for the CQA team on inspectors and potential changes in regulations across the GxPs.
- Interfaces with relevant departments, including regulatory, clinical outsourcing, clinical sub teams and others, as applicable, to provide Good Clinical Practice and QA compliance expertise.
- Establishes and maintains a system to ensure R&D Management Reviews
- Support Training coordinator and CQA Training Curriculum liaison
- Develops and mentor direct reports for leadership opportunities
- Identifies continuous improvement opportunities, new technologies, and innovations and implement processes and system that increase efficiency and compliance.
- Assist Director, QMO on development and management of Quality Systems and SOPs in CQA.
- The candidate must be able to solve problems, communicate effectively, and trouble-shoot creatively
Requirement and Experience :
- Management of CAPAs and Deviations
- Experience with Trackwise, Veeva or Master Control eQMS in the various modules, audit, CAPA and Deviations etc.
- Proficiency in MS Office applications
- Bachelor’s Degree or equivalent combination of education and experience
- 8+ years of industry experience
- Understanding of regulatory trends, regulations, and guidelines such as GCPs, ICH E6 R2/R3, 21 CFR Part 11, EU PV Regulations
- Ability to evaluate and apply compliance requirements/guidelines to applicable situations
- Excellent multi-tasking, analytical, organizational and leadership skills.
- Experience leading teams and handling project management activities without supervision
- Strong communication skills and technical writing ability
- Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software
- Travel required - 30% (Domestic and International)
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)