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. Summary of the Position
The Sr. Manager reports to the Director of CQA with primary responsibilities for:
- Leading and conducting GCP audits of Clinical investigator Sites to assess
compliance with study protocol, applicable regulations, guidelines policies,
procedures and sponsor requirements;
- Preparing and executing risk-based investigator site audit plans, supporting
scheduling and reporting of CI site audits;
- Providing support for GCP regulatory authority inspections of sponsor, clinical
investigator sites and external service providers, where applicable;
- Providing GCP guidance to clinical study teams, evaluating and processing potential
quality issues, escalations and potential serious breaches.
**This position must be flexible and open to travel** Core Functions
- Prepare and execute risk-based Investigator Site Audit program;
- Plan, organize and lead audits of clinical investigator sites for compliance to protocols,
policies, SOPs, and applicable regulations;
- Effectively communicate audit results, both orally and in writing;
- Review corrective and preventive action plans/audit responses for adequacy;
- Interpret, explain, and apply the applicable GCP current regulations, guidelines,
policies, and procedures for GCP site audits, support of clinical teams, escalating and
supporting processing of potential quality issues, escalations and potential serious
- Quality review of clinical documentation, such as protocols, informed consent forms
and Investigators Brochures, according to applicable sponsor procedures and
- Review and evaluate the potential risk of compliance and quality issues;
Provide QA support to, and interact with, internal functions, service providers and
CROs on issue management and escalation process;
- Ensure quality agreements, standards and specifications are maintained where
- Assist CQA management in the development, revision and implementation of QA and
cross functional strategic processes, procedures and work practices to ensure
continuous quality improvement;
- Maintain effective communication of project related information;
- Provide training and consulting services to the organization to ensure GCP compliance;
Requirements and Experience
- Knowledge of, and remains up to date with, current GCP regulations, guidance, FDA,
EU, and other regulatory bodies (relevant to NVAX activities);
- Consistently demonstrating and promoting a collaborative work approach, promoting
team work, team building and leadership;
- 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 in a Life Science, nursing or pharmacy is preferred;
- 5+ years’ experience in global GCP Regulations and guidance;
- 3+ years of leading and conducting GCP audits on Clinical Investigator Sites (must);
- Understanding and ability to interpret and apply FDA/EMA/MHRA/other regulatory
authority regulations, and guidelines such as GCPs, ICH E6, 21 CFR Part 11
- Ability to evaluate and apply compliance requirements/guidelines to applicable
- Excellent multi-tasking, analytical, organizational and leadership skills;
- Experience participating in teams and handling project management activities with
- Demonstrated ability to manage process improvement projects;
- Strong communication skills and technical writing ability;
- Ability to adapt to changing environment and 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)