Senior Director, Quality Control

Published
September 12, 2018
Location
Gaithersburg, MD
Category
Default  
Job Type

Description

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.

The Senior Director of Quality Control is responsible for organization and oversight of the company's Quality Control testing laboratories and related support functions in support of GMP operations.  Quality Control performs testing in compliance with applicable guidelines and regulations.  The Senior Director of Quality Control will provide leadership, management and technical skills to integrate and coordinate activities in alignment with other departments and corporate goals.  He/she will manage team and projects based on short-term and long-term objectives.  The scope of work includes assay testing, environmental monitoring, management of external testing labs, and execution of assay validation protocols, and other duties as assigned by the SVP, Global Manufacturing Operations.

Responsibilities include but are not limited to:

  • Develop a culture in the QC department of open communications and collaboration.
  • Maintain and operate the company's Quality Control testing laboratories, equipment, standards, and procedures in compliance with GMP standards.
  • Develop, maintain, and perform environmental monitoring of the GMP manufacturing facilities.  Perform data reviews and complete required reports.
  • Prepare, review, and approve external and internal protocols and other documentation as required to support external testing lab services.
  • Leveraging Operational Excellence (OE) tools and in collaboration with the OE staff, identify and implement initiatives designed to improve the performance, efficiency, and accuracy of quality control functions and personnel.
  • In collaboration with the Quality Assurance department, provide technical expertise and assist in the development and maintenance of raw material specifications.
  • Perform and complete Change Control, Investigations, and Corrective/Preventive Actions associated with QC and/or process deviations.
  • Prepare QC organization for successful regulatory inspections and audits.
  • Effectively cooperate with departments across the company to analyze and resolve technical issues in accordance appropriate quality standards
  • Performs special assignments in assay tech transfer, validation, or other technical projects as assigned by the SVP, Global Manufacturing Operations.
  • Develop and maintain collaborations with counterparts at Novavax subsidiaries and partners (e.g.  Novavax, AB and CPLB)

Minimum requirements:

  • Bachelor's degree in biological science.  MS/Ph.D. preferred.
  • 10+ years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing. (Vaccine manufacturing experience highly preferred)
  • Minimum 5 years laboratory based analytical methods experience
  • Minimum 5-7 years supervisory experience.
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
  • Knowledgeable of FDA regulations and ICH Guidelines regarding the manufacture of biological products.
  • Knowledge of quality compliance standards and risk management.
  • Experience running a QC laboratory for a commercial product is preferred.
  • Excellent multi-tasking, analytical, organizational and leadership skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs.
  • Knowledge of government contracting processes a plus.

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/885600-222192

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