Novavax
  • 29-Aug-2017 to 28-Oct-2017 (EST)
  • Clinical Quality Assurance
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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.  

 

We are seeking a highly motivated and experienced individual for a Sr. Director/Director position in Clinical Quality Assurance.  This position is located at our Gaithersburg, MD facility and will report to the Vice President, Quality Assurance.  The position will work in in close collaboration with the Regulatory Affairs, Clinical Operations, Pharmacovigilance, and the Quality Assurance departments and the Chief Medical Officer to provide the organization with the leadership required to develop, implement and maintain quality systems and standards that ensures the Company is in compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).  The Sr. Director/Director of CQA will be responsible for ensuring clinical processes and nonclinical activities are conducted in accordance with guidelines and regulations.

 

Responsibilities include but are not limited to:

  • Develop, implement, maintain, monitor, and improve the clinical quality assurance system and function.
  • Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management and risk assessments.
  • Educates and drives a quality risk management culture and manages/escalates the company's compliance risks and visibility to Sr. Leadership.
  • Review and approval of development reports, qualification reports, validation protocols, reports, and amendments, nonclinical protocols and reports, change controls, CAPAs, CAPA plans and deviations.
  • Assure that effective auditing functions are in place and executed to address company requirements for vendor/subcontractor qualification audits (clinical and nonclinical), global clinical investigator site audits, clinical immunology laboratory audits (internal and external),  nonclinical data, internal and external databases (e.g. clinical studies and safety databases), key deliverables/study components  (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE).
  • Administration and oversight for internal and clinical site training, clinical and nonclinical investigations, databases for the quality system, annual reports and quality trending reports, and evaluation of quality events, incidents, and complaints.
  • Provides mentorship, leadership, and prioritization to staff to execute their respective duties.
  • Stays current with related quality legislation, compliance issues, and is an internal Novavax subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents and best industry practices.
  • Effectively cooperates with departments across the company to analyze and resolve technical issues in accordance appropriate quality standards
  • Supports regulatory inspections as necessary including contributing to the preparation, conduct, and responses to regulatory agencies

 

Minimum Requirements:

  • BS/MS in a related science field
  • 15+ years' experience in Clinical Quality Assurance
  • 10+ years' supervisory experience.
  • Comprehensive knowledge of drug development process, drug laws, regulations and guidelines
  • Proficient in major regulatory e-submission software, as well as Microsoft Office suite (Word, Excel, PowerPoint)
  • Ability to work independently and within a group setting and to interact effectively with different functional departments
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
  • Ability to establish and build collaborative relationships with staff, colleagues, and regulatory authorities
  • Demonstrates flexibility in dealing with change and diversity
  • Possesses strong critical and logical thinking

 

Novavax 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.

 

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

Novavax
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