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.
We are seeking a Clinical Quality Assurance Specialist III to join our Clinical Quality Assurance (CQA) Department. The qualified individual should have experience with US and international Good Clinical Practice (GCP) regulations, guidance documents, and industry best practice in the areas of a GCP environment.
Responsibilities include but are not limited to:
- Leads audits to ensure compliance to protocols, regulatory regulations, commitments, industry best practices and guidance's.
- Conducts GCP audits in support of Clinical Study Teams, Clinical Sites and vendors.
- Conducts external laboratory audits (e.g. Immunology and specialty labs, academic labs and central diagnostic laboratories) to GCP, GCLP and best practices.
- Evaluates Clinical and Regulatory documents (e.g. protocols, amendments, Trial Master Files, Informed Consents, final reports, SOPs) for adequacy and compliance.
- Supports Clinical Trial Management, temperature excursion evaluation, vendor complaint process and risk management collaboratively; with routine management oversight.
- Author's CQA SOPs and reviews Clinical Operations SOPs.
- Participates in CQA Internal Audit and Vendor Quality Programs
- Proficient knowledge of GCP, GCLP, GLP and cGMP.
- Provides training, guidance, and interpretation of regulations, GCP guidelines.
- Reviews, tracks and trends, routine quality data. Reports metrics and adverse trends to management with potential remediation plan for complex issues.
- Stays current with amendments to GXPs, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance documents bodies to support NVAX's clinical programs.
- Initiates and leads continuous quality improvement at Novavax.
- Bachelor's Degree or higher, in a related science field.
- A minimum of 5+ years in Clinical (GCP) Quality Assurance.
- Strong knowledge of GCP regulations and minimum of 5 years in an auditing role.
- Good knowledge of GLP regulations and GCLP Guidelines.
- Proficient in Microsoft Office suite (Access, SharePoint, Excel, PowerPoint and word).
- Ability to identify opportunities and changes in priorities making adjustments as needed.
- Ability to interact effectively and independently and within a group setting.
- Excellent multi-tasking, reasoning, trouble-shooting and root-cause analysis
- Reaches established goals/targets for moderately complex tasks with the involvement of teammates within commitments.
- Demonstrates flexibility in dealing with change and diversity.
- Individual must be willing to travel domestically and internationally (25 %+), as needed.
Additionally, we prefer candidates that have the ability:
- To effectively build/maintain cross-functional relationships to effectively solve problems.
- To organize, prioritize and deliver tasks according to pre-defined deliverables.
- To enable and drive change while being focused on clinical internal customers.
- To provide excellent communication (verbal and written) across functions internally and externally to Novavax partners and vendors.
- Capable of managing multiple priorities.
- Produces high-quality work on complex problems with cross-functional involvement.
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.