Senior Manager, Clinical Quality Assurance (CQA)

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
25 Jan 2023
Closing date
24 Feb 2023

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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
    breaches;
  • Quality review of clinical documentation, such as protocols, informed consent forms
    and Investigators Brochures, according to applicable sponsor procedures and
    applicable regulations;
  • 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
    required;
  • 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;

Core Skills :
  • 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.

Requirements and Experience :
  • 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
    situations;
  • Excellent multi-tasking, analytical, organizational and leadership skills;
  • Experience participating in teams and handling project management activities with
    limited supervision;
  • 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.

#LI-DC

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)

Company

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

 

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Find Us
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
US

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