Manager/Sr Manager, Clinical Quality Assurance Compliance

Full time Full day
Gaithersburg, MD

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.

We are seeking a QA Compliance Manager/Sr. Manager to join our Clinical Quality Assurance (CQA)group The qualified individual should have experience with US and international GCP/PV/GCLP regulations, guidance documents, and industry best practice in all areas of a GxP environment.

Responsibilities include but are not limited to:

  • Participates in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management

  • Works with internal and external GCP/PV entities and develop and execute strategic audit plans.

  • Supports the development and/or review of GCP/PV audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.

  • Supports the development, implementation and maintenance of CQA systems and SOPs for GCP/PV systems

  • Leads internal and external audits of the various quality elements to ensure compliance to GCP/PV/GCLP regulatory commitments and requirements, industry best practices and guidances

  • Act as a contact with members of Regulatory Authorities and / or vendors; assist and lead inspections / audits, in agreement with QA management.

  • Participates in company preparations for regulatory inspections, which may include reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.

  • Evaluates and presents solutions on complex issues with minimal input from senior staff

  • Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies.

  • Reviews, tracks and/or trends routine quality data. Reports adverse trends to management with remediation plan.

  • Performs final quality review/assessment for new Clinical Vendors/CROs

  • Trains and mentors junior staff

  • Independently writes and implements controlled documents (i.e., SOPs, Policies, Audit reports) which may entail significant system changes

  • Stays current with changes to current GCP/PV/GCLP regulations, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance bodies so that NVAX's compliance policies are current and effective.

Minimum Requirements:

  • Bachelor's degree in biological science is required.

  • 8+ years' experience in GXP pharmaceuticals, biologics and/or vaccine clinical research.

  • 5+ years industry experience in an auditing role

  • CQA/RAPS or other audit certification is highly preferred.

  • Knowledgeable in principles and current GCP/PV/GCLP in a clinical development to commercial application setting.

  • 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 Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.

  • Individual must be willing to travel domestically and internationally (30-50%), as needed.

Additionally, we prefer candidates that have:

  • The ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in order to effectively solve problems.

  • The ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.

  • The ability to enable and drive change while being focused on internal customers.

  • Excellent communication skills both verbally and written; and across functions internally and externally to Novavax.

  • Capable of managing multiple priorities.

  • Produces high-quality work on complex problems with cross-functional involvement. Anticipates and proactively prevents risks and compromises to quality

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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