• 14-May-2021 to 13-Jul-2021 (EST)
  • Quality Assurance
  • Gaithersburg, MD, USA
  • Contract

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

We are seeking a Quality Assurance Sr. Manager to join our Quality Assurance department in Gaithersburg, MD. The Sr. Manager will oversee a staff of QA specialist performing review and approval of executed GMP records in support of lot release and stability. The candidate will conduct batch release approval and manage the review and approval of records generated in support of the development, qualification, validation and tech transfer activities. The Sr. Manager will also interact with functional groups to resolve discrepancies including review and resolution of deviations, OOS and other investigations.

**Must be flexible and open to travel**

This position reports to the Sr. Director of Clinical QA Inspection Management.

Responsibilities include but are not limited to:

  • Participates in oversight and management of Investigator Site Audits, Internal Audits and Vendor Quality Programs with minimal guidance from management
  • Provides quality oversight for clinical development programs and studies, including data integrity and protection of clinical study participants
  • Collaborates with Clinical Compliance Lead to ensure that clinical development programs and clinical trials are compliant throughout the life cycle of the program and trials
  • Leads internal and external audits and audit programs of the various quality elements to ensure compliance to regulatory requirements, industry best practices and guidances
  • Evaluates and presents solutions on complex issues (i.e., major deviations, non-compliances, CAPAs, etc.) with minimal input from senior staff
  • Reviews, tracks and/or trends routine quality data. Reports adverse trends to management with proposed remediation plan.
  • Performs final quality review/assessment for new suppliers and service providers Performs review of all quality-related documentation and events to ensure data integrity and protection of clinical studies participants
  • Trains and mentors junior staff Independently writes and implements controlled documents (i.e., SOPs, Policies,
  • Protocols, etc.) which may entail significant system changes
  • Stays current with changes to current GCP/GLP/GCLP regulations, guidance, safety reporting including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and so that NVAX's compliance policies are current and effective.
  • Performs lead role on complex issues with minimal input from senior staff
  • Reviews & Approves Deviations, CAPA and other compliance documentation Develops and delivers training for individual and group settings
  • Manages projects and delivers outcomes within desired timeline
  • Identifies and coordinates resources and effectively communicates process, outcomes, and timelines
  • Supports local and global Quality Assurance functions
  • Other duties as assigned

Minimum Requirements:

  • Bachelor's degree in science is preferred.
  • 5+ years' experience in global GCP/GCLP/GLP/PV Regulations and guidance
  • 3+ years industry experience in an auditing role
  • Excellent multi-tasking, analytical, organizational and teamwork skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • Proficient in MS Window based software to include Excel and Word. Ability to adapt to changing software programs.
  • Individual must be willing to travel domestically and internationally (30%), as needed.
  • Excellent communication and organizational skills

Additionally, we prefer candidates that have:

  • Established recognition as a technical expert
  • Demonstrated success leading multiple teams
  • Demonstrated complex problem resolution through assignment of work to staff
  • Demonstrated ability and willingness to perform tasks with increasing independence and complexity
  • The ability to represent QA cross-functionally and globally; to apply understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
  • The flexibility to influence cross functional team members to ensure compliance
  • The accountability to attain confidence in achieving complex deliverables requiring cross-functional and, at times, global involvement
  • The ability to produce high-quality work on complex problems with cross-functional and global impact; to take ownership of quality considerations and standards across the team's work product
  • Agility and prioritization skills

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

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.

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