Full-Time

Sr. Business Process Manager

Digital Quality

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Norwood, MA, USA

70/30 work model requires 70% in-office presence.

Category
Project Management
Strategy Development
Business & Strategy
Requirements
  • Bachelor’s degree in science, technology, or another relevant academic discipline
  • 8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company.
  • Experience with GAMP and GxP compliance regulations
Responsibilities
  • Drive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise.
  • Execute on our Digital Quality strategy with clear communication, prioritization, and escalation, both within Digital Quality and other cross functional teams
  • Mentor a team of internal and external business analysts and software engineers designing, implementing, and maintaining our electronic quality management system, Veeva Quality
  • Partner with digital stakeholders to ensure successful planning and integration of key systems into the quality management system while looking out for automation capabilities, and any artificial intelligence initiatives.
  • Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.
  • Support the Digital Quality Leadership Team by managing action plans and project plans to deliver short-, mid-, and long-term quality goals.
  • Apply an operational excellence mindset to help Identify, devise, and recommend new opportunities to optimize current processes.
  • Define and deliver a consistent systems governance methodology across applications with clear roles and responsibilities established throughout the system lifecycle: Implementation, Enhancement, and Support
  • Ensure GxP compliance is built into the design, delivery, and maintenance of all systems.
  • Maintain inspection readiness through adherence to internal quality policies, procedures, and training.
  • Participate in internal and external audits as digital quality expert for portfolio of processes.
  • Hit the ground running immediately and work closely with various stakeholders in Quality to enable sustainable commercial operations.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves using mRNA to instruct cells to create specific proteins that can help treat diseases. This method differs from traditional drug development by potentially allowing for faster and more efficient creation of vaccines and therapies. Unlike many pharmaceutical companies that rely on established methods, Moderna is at the forefront of mRNA technology, aiming to transform the way medicines are discovered and manufactured. The ultimate goal of Moderna is to improve patient outcomes by harnessing the power of mRNA to create new treatments.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

12%

2 year growth

54%
Simplify Jobs

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.

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