Director/Sr. Director, Clinical Quality Assurance

Novavax Gaithersburg , MD 20877

Posted 3 months ago

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 highly motivated and experienced individual for a Sr. Director/Director position in Clinical Quality Assurance (CQA). This position is located at our Gaithersburg, MD facility and will report to the Vice President, Quality Assurance. This position's primary responsibility is to be the strategic and operational leader for this group. This position will manage and direct the ongoing CQA activities to support GLP, GCP, GCLP, and other GxP work in ongoing and planned clinical trials, as well as clinical laboratory activities. It requires direct successful interface with Clinical Operations, Pre-Clinical and Clinical Laboratories, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, as well as external contract auditors and clinical sites.

Responsibilities include but are not limited to:

  • Global design and strategy, development, deployment, and continuous improvement of CQA systems and functions.

  • Directly interact with Clinical Operations and Clinical Immunology to assure that effective CQA 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), and key deliverables/study components (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE).

  • Educates and drives a quality risk management culture and manages/escalates the company's compliance risks and visibility to Sr. Leadership, including creation, tracking, and assisting in presenting metrics on the health of CQA systems on a frequent basis to stakeholders and Senior Management.

  • Review and approval of development reports, qualification reports, validation protocols, reports, and amendments, nonclinical protocols and reports, CAPA, and deviations.

  • 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 and communicates with departments across the company to analyze and resolve technical issues in accordance with appropriate company 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, 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.

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Director/Sr. Director, Clinical Quality Assurance