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

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. 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.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Summary of the Position:

We are seeking a Director of Quality Operations to join our Quality Assurance Operations team in Gaithersburg, MD. The Quality Operations Director will be responsible for support of GMP production activities at CMO with a focus on Manufacturing areas. The candidate will provide critical oversight, communication and organization of record lifecycle generated during GMP manufacturing and release at CMO(s).

This position reports directly to the SR Director of QA Operations.

Responsibilities include but are not limited to:

• Provide QA oversight of main CMO responsible for the manufacturing of Drug Substance and Drug Product
• Key point of contact with Quality lead and responsible to drive Novavax team to meet timeline for deliverables-batch review, quality records and batch disposition
• Capable of leading on behalf of Novavax
• Responsible for proactive monitoring the performance of CMOs/ to ensure that they remain in a state of control are aligned to metrics/ expectations, and leading the effort to drive improvement
• Responsible for the development & assessment of quality metrics, KPIs and reports associated with CMO’s / CTL’s and to recommend actions as a result of such reviews / reports.
• Represent QA CMO/ CTL management team with cross functional project teams
• Responsible to ensure appropriate escalation, communication channels are used to ensure senior management are kept informed of critical issues, as required.
• Accountable for deployment of Global Quality Standards within the function
• Support internal and regulatory agency inspections at CMO
• Responsible to ensure on time execution of activities and team timeline adherence
• Proactively identifies and drives remediation of risks within sphere of influence.
• Responsible for hosting meetings with external parties and representing Novavax in a professional manner
• Management of critical issues and timely resolution, developing solutions to complex problems.
• Oversee timely reporting and closure of Quality events- changes, deviations, OOS, complaints
• Partner with the PIPs to drive thorough and timely batch review and issue management and drive improvements at the CMO
• Responsible to work with CMO compliance lead to ensure CMO’s/ CTL’s are inspection ready.
• Conducts final review and approval of manufacturing-related documentation prior to batch release approval
• Preparation of batch disposition documents for review and approval.
• Serves as a technical resource or subject matter expert on manufacturing and techniques within Quality Assurance for CMO relations
• Review and approval of manufacturing technology transfer, qualification, and validation documents internally and oversight activities to CMOs.
• Provide Quality support and oversight for resolution of deviations and non-conformances related to manufacturing activities.
• Provide Quality review and approval for Process Descriptions and executed batch records.
• Provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned.
• Maintaining tracking system for respective CMO(s) activities
• Assist management with other non-routine projects as assigned.
• Other duties as assigned.

Minimum Requirements:

• Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 13+ years’ experience in the Pharmaceutical/Biotech industry with 6+ years supervisory experience
• Excellent Project Management skills
• Excellent understanding of Quality Assurance systems and CMO requirements
• Excellent multi-tasking, analytical, organizational and leadership skills
• Excellent understanding of GMP, GLP, GCP and GCLP expectations
• Knowledge of global regulatory expectations (including FDA and EMA)
• This is a hybrid role. Interested candidates must be located on the east coast and within driving distance of Gaithersburg, MD.

Additionally, we prefer candidates that have:

• The established recognition within QA as a technical expert
• Demonstrated success in leading problem resolution
• Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
• The ability to represent the team cross-functionally; to apply an 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 strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context
• The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and beyond
• The ability to produce high-quality work on complex problems with cross-functional involvement; to anticipate and proactively prevent risks and compromises to quality
• The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues.
• The capability to consistently develop networks that are diverse in level and function, identify and initiate new relationships as well as creative alliances to accomplish business objectives, and inspire people with diverse needs to work together for mutual benefit
• This position may require frequent weekend/evening/early work and 30% travel.

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.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)