Full-Time

QA Operations Head

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior, Expert

Oxford, UK

Related job location is Harwell, UK.

Category
QA & Testing
Quality Assurance
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 crucial component in how cells produce proteins necessary for biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treating diseases. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to improve patient outcomes by harnessing the power of mRNA to create effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

0%

1 year growth

2%

2 year growth

3%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna received a $176 million contract for a bird flu vaccine.
  • The company is expanding mRNA applications to personalized cancer vaccines.
  • Moderna is establishing a domestic mRNA production facility in Australia.

What critics are saying

  • Potential backlash in Australia for bypassing vaccine safety steps.
  • Possible removal from Nasdaq 100 Index could affect investor confidence.
  • Hong Kong residents' reluctance to get vaccinated may hinder market penetration.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for new categories of medicines.
  • The company integrates AI to optimize mRNA design and production processes.
  • Moderna's mRNA platform enables rapid development of vaccines and therapeutics.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Sabbatical Leave

Hybrid Work Options

401(k) Company Match

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Adoption Assistance

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend

INACTIVE