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Full-Time

QA Operations Head

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Senior

Oxford, UK

Category
QA & Testing
Quality Assurance
Required Skills
Management
Quality Assurance (QA)
Requirements
  • Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience
  • 8 – 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
  • Demonstrated ability making risk based decisions
Responsibilities
  • Managing a team of QA professionals responsible for on-the-floor manufacturing oversight, deviation management, change management, batch record review, and product disposition.
  • Enforcing adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
  • Monitoring key quality system metrics and process indicators to ensure compliance and performance expectations.
  • Being a role model for Quality Culture and embodying the Moderna Mindsets, collaborating closely with cross-functional partners as an active member of leadership.
  • Supporting the training and development of the QA team, including coordination of training, capability assessment and enhancement, and professional development.
  • Authoring, reviewing, and/or approving documentation, including SOPs, to ensure compliance and adherence to regulations/cGMP operations.
  • Championing continuous improvement in all aspects of total quality management.
  • Interfacing directly with Local Health Authorities or other regulatory authorities, ensuring inspection readiness, and providing guidance and support relative to Good Manufacturing Practices (GMPs).

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

8%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.