Skip to main content

This job has expired

Distribution Quality - Manager

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
26 Sep 2022
Closing date
25 Oct 2022

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 Distribution Quality - Manager to join our Quality Ops Materials department in Gaithersburg, MD. This position is responsible for routine Quality oversight of Supply Chain and Distribution and associated materials management activities. The position is responsible for ensuring the warehouse and area personnel activities remain in compliance with CFR, FDA and ICH Guidances, global regulatory expectations, and international cGMPs. Responsibilities include providing quality oversight for area specific change controls, deviations and CAPAs and participating in and reviewing investigations. The position will provide quality oversight for Materials Management including transportation, receiving, materials storage and materials management operations at the internal and external manufacturing warehouse.

This position reports directly to the Quality Assurance Director.

R esponsibilities include but are not limited to :
  • Collaborate cross-functionally with CMC stakeholders (Supply Chain Planning, Quality Control, Manufacturing, Quality Assurance, Trade and Distribution) to enable end-to-end supply chain
  • Create and/or approve SOPs, temperature deviation investigations, and change controls as part of GMP quality compliance. Contribute to contract reviews such as Quality or Supply Agreements
  • Quality oversight for domestic and international shipments through delivery, including transactions for reconciliation in SAP.
  • Ensure shipping and handling and storage are in line with quality requirements
  • Support Supply Chain department projects to improve areas such as cold chain management, customer service, training and best practices, audit readiness, and thermal packaging needs
  • Provide guidance and oversight for Materials Management, and Supply Chain activities such that they always remain GMP compliant
  • Provide Quality oversight of day-to-day shipping, receiving, materials storage and issuance, and other Materials Management and Supply Chain activities
  • Provide guidance and support in responding to deviations associated with warehouse and materials management operations. Confirm thorough and effective CAPAs are implemented as necessary
  • Drive and oversee improvements in warehouse and materials management processes, procedures, and work instructions
  • Ensure that change controls for the area adhere to requirements and provide area impact assessments for change controls
  • Responsible for quality oversight of shipping requirements, temperature excursions
  • Communicate with Distribution/Supply Chain management for Quality related issues
  • Notify Quality Management of any quality issue that may be regulatory significant or impact the acceptability of product or materials
  • Work with internal contracting groups to develop, implement and manage distribution contracts and pull through strategies with customers to support launch efforts and ongoing collaborations
  • Monitor and evaluate new distribution initiatives for execution and compliance
  • Contribute to weekly distribution team meetings
  • Develop a system to track performance metrics and coordination of performance improvement initiatives, report on those metrics
  • Write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications

Minimu m Requirements :
  • Bachelor’s Degree in Biology, Chemistry, Engineering, BS with 7+ years’ experience in the Pharmaceutical/Biotech industry
  • Strong knowledge foundation of FDA and EU regulations regarding the manufacturing of biologics (210, 211, and 610 CFR and Eudralex Vol 4)
  • Understanding of Quality Assurance systems
  • Strong communication and organizational skills

Preferred Requirements :
  • Demonstrated ability to manage multiple priorities and maintain adherence to timelines
  • Demonstrated ability to lead and develop more junior employees
  • Demonstrated ability to manage process improvement projects
  • Demonstrated ability to identify and implement cross-functional improvements
  • Demonstrated ability to maintain relationships across the organization
  • Demonstrated knowledge of quality systems
  • Demonstrated ability to lead complex investigations with minimal supervision

This position may require periodic weekend/evening work.

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.

#LI-DC

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)

Company

Find out more about working for our company

novovax-hub-button

Brief Company Description; 

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Company info
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
United States

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert