Supervisor, Clinical Quality Assurance, 1st Shift
ModernaTX, Inc.

Job Info

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The Role:

Moderna is seeking a Quality Assurance Supervisor to lead a team of QA Associates/Specialist responsible for quality oversight of clinical operations at Moderna Inc. This position will be 1st shift working Wednesday to Saturday, based at the clinical manufacturing site located in Burlington, MA.

This position is part of Moderna's Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in clinical manufacturing. The main responsibility is to provide real time quality leadership and, on the floor, operational support for the clinical manufacturing team.

The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical and commercial products. Strong decision-making skills and independent thinking will be paramount for candidate success. Candidate will interact fluidly with site management in Manufacturing, and cross-functionally within the Quality organization.

Here's What You'll Do:

• Manage Moderna's Clinical Quality team responsible for providing on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues.
  
• Make quality decisions that may impact operations, ensuring appropriate escalation.
  
• Coordinate training, professional development and growth of the Clinical Quality Assurance team at the Burlington site.
  
• Monitor process operations to ensure compliance with procedures and specifications.
  
• Demonstrate knowledge of standard manufacturing compliance, quality disposition, quality system review.
  
• Identify risks and communicate gaps for quality and GMP process/systems
  
• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
  
• Partners with manufacturing and support management teams to focus on site initiatives.
  
• Oversee and perform review of executed electronic and paper batch record documentation, as applicable.
  
• Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
  
• Utilize knowledge to improve operational efficiency.
  
• Collaborate and lead effectively in a dynamic, cross-functional matrix environment.
  

Here's What You'll Bring to the Table:

• Minimum of 6 years of experience in a GMP manufacturing environment, preferably within Quality, with a Bachelor's Degree in Life Science; and at least 1-year leading teams.
  
• Proven track record of success in a fast-paced production environment at a GMP biotech/pharmaceutical company.
  
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
  
• Outstanding communication skills (verbal and written).
  

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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