Senior Manager, Quality Operations (CMO)

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:

Reporting to the Quality Operations Sr. Director, the Sr Manager for Quality Operations CMO, is responsible of leading GMP compliance with a focus on the management of Deviations, Change Controls, CAPAs, and the implementation of Quality Metrics with additional responsibilities for the Quality oversight of records generated during GMP manufacturing of biotechnologically produced vaccines in a fully functional GMP Contract Manufacturing Organization (CMO) manufacturing facility. The candidate will manage the review and approval of records generated in support of the development, qualification, validation, and tech transfer activities.  The Sr. Manager will also interact with functional groups to resolve discrepancies including review and resolution of deviations, OOS, and other investigations. The Sr Manager will be the PoC (Point of Contact) for the CMO that will be his/her responsibility.

Responsibilities:

• Represent Novavax Quality in CMO relationships, provide leadership and guidance for team members working with CMOs, and engages frequently with CMOs regarding Quality oversight, solutions, and outcomes.
• Provide management oversite for the review and approval for manufacturing readiness-controlled documentation including, but not limited to master & executed batch records including sampling plans, raw material specifications, validations documents and labeling proofs.
• Serves as a technical resource or subject matter expert on the acquisition and use of GxP-related technology
• Manages a team of CMO QA Specialist and Quality Persons in Plant (PIP)
• Manages day to day tasks for junior employees.
• Performs lead role on complex issues with minimal input from senior staff and communicates appropriately
• Conducts final review and approval of development, QC and manufacturing-related documentation prior to batch release approval.
• Responsible for the review and status tracking of production lots
• Conducts batch disposition approval as need it
• May initiate and own Deviations, CAPA and Change Controls
• Review & Approves CMO Deviations, CAPA and Change Controls
• Manages the execution, review, and approval of qualification, validation, and tech transfer activities.
• Delivers training for individual/small group/large group training.
• Manages projects and delivers outcomes within desired timeline.
• Identifies and coordinates resources and effectively communicates process, outcomes, and timelines
• Supports global Quality Assurance functions.
• This job can include night and weekend work
• 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.
• Responsible to facilitate CMO Quality Review Meetings on a Quarterly Basis
• Drive and/or facilitate continuous improvement projects
• Ensure compliance by maintaining training completion on time
• Assist management with other non-routine projects as assigned.
• Other duties as assigned

**Must be flexible and open to travel / This position may require periodic weekend/evening work **

Requirements:

• BS with 10+ years’ experience in the Pharmaceutical/Biotech industry with 5+ years supervisory experience
• Excellent understanding of Quality Assurance systems
• Ability to lead teams and manage competing priorities
• Strong communication and organizational skills
• Excellent understanding of GMP, GLP, GCP and GCLP expectations
• Knowledge of global regulatory expectations (including FDA and EMA)
• The established recognition within QA as a technical expert
• Demonstrated success in leading investigations and problem resolution
• Demonstrated success leading a team and training junior staff.
• Demonstrated interest and ability to manage technical, operational, and administrative aspects of the team
• 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.

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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