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.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Clinical Development Oncology

Astrazeneca

Posted 1 week ago

VIEW JOBS 12/6/2018 12:00:00 AM 2019-03-06T00:00 If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us. MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As Associate Director / Director, Clinical Development – Oncology in Gaithersburg, MD, or Granta Park, Cambridge UK, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules. MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Main Duties and Responsibilities This is a unique opportunity to join MedImmune at a time of tremendous growth and acceleration in the oncology biologics portfolio. This is a fast-paced and dynamic work environment where, with increasing levels of responsibility, you will be responsible for medical monitoring of ongoing clinical trials, the planning and conduct of clinical trials, providing long-range clinical development planning, planning and managing of clinical research projects and clinical development programs in oncology, collaborating with and providing clinical input and expertise to pre-clinical and translational sciences, and setting and achieving goals and meeting timelines in accordance with corporate goals and budgets. You will serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development. You will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio. You will be a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel immuno-oncology therapies for cancer patients, and have the opportunity for growth and development while working in a vibrant environment and "biotech" culture. Additionally, you will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. Specific duties and major responsibilities include the following: Serve as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance; Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports; Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical oncology; Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products; Provide leadership on cross-functional product development team(s) as experience allows; Participate in identification, selection and conduct of negotiations with clinical research centers and investigators; Participate in the selection and management activities of CROs; Supervise project team members in planning, conducting and evaluating clinical trials; Oversee planning and management of investigator meetings, advisory boards and other scientific committees. NOTE: This position can be located in either the US (Gaithersburg, MD) or UK (Granta Park, Cambridge) Essential Requirements For Associate Director level: * At least 1-2 years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical or CRO environment For Director level: * At least 2-5 years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment. Desirable Requirements * Current medical license * Immuno-oncology development experience * Experience in molecular oncology and/or translational science * Medical specialty and sub-specialty training and certification (or eligibility in medical oncology * Excellent oral and written skills, strong interpersonal and listening skills * Results driven to achieve creative and sound outcomes * Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment. * Ability to make sound and timely decisions; agile in learning and action oriented * High level of emotional intelligence; able to deal with ambiguity * Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams Next Steps – Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. Astrazeneca Gaithersburg MD

Director/Sr. Director, Clinical Quality Assurance

Novavax