QA Technical Operations Lead - Oxford, United Kingdom - Moderna

Moderna
Moderna
Verified Company
Oxford, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description

The Role:


Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.


Our presence in Oxford, at the heart of the UK's rich scientific landscape, is a testament to Moderna's commitment to innovation and excellence.

As the QA Technical Operations Lead, you will be immersed in an environment that thrives on cutting-edge biotechnology, alongside team members dedicated to transforming the field of medicine.

Oxford's vibrant academic and research community provides an unparalleled opportunity to collaborate with leaders in the industry and academia, furthering our mission to pioneer breakthroughs in healthcare.


You will be an integral member of the Quality Assurance team, reporting directly to the Site Quality Head at our Oxford facility.

This role demands a professional who exhibits dynamic range and offers a unique blend of quality oversight for manufacturing operations, contamination control, sterility assurance activities, and technological transfer projects within a cGMP mRNA drug substance production setting.

As a visionary in sterility assurance, you will be pivotal in leading quality initiatives and fostering a culture of excellence in our processes.


Here's What You'll Do:

Your key responsibilities will be**:
Spearheading the implementation of company policies and strategies around low bioburden drug substance processing and aseptic techniques.

Establishing and upholding contamination control strategies and overseeing aseptic practices.

Generating vital contamination control strategy documents.


Your responsibilities will also include:

Providing Quality oversight across commissioning, qualification, and validation projects.

Leading Quality oversight of product Technology Transfers and significant deviation management.

Reviewing and approving critical GMP documentation and participating in audits and inspections.


The key Moderna Mindsets you'll need to succeed in the role:

Act with urgency:

In a role critical to our operations, your immediate actions will have a lasting impact on our ability to deliver life-saving treatments.


Pursue options in parallel:

Your ability to multitask and manage concurrent projects will be essential in choosing the most effective strategies moving forward.


Here's What You'll Bring to the Table:
Bachelor's Degree in a science field (preferably microbiology) or related field.

Experience in Biopharmaceutical Industry.

Technical knowledge of contamination control & sterility assurance requirements with demonstrated experience of implementation responsibility.

  • 10 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices


Strong working knowledge of worldwide regulations related to sterility assurance, contamination control strategies and associated risk assessments and the ability to interpret these requirements into execution principles.

Experience interacting with regulatory authorities during regulatory inspections.

Demonstrated ability making risk-based decisions


Strong leader and cross functional team player with the ability to work effectively in a fast-paced environment while managing multiple projects simultaneously.


Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras


The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.

We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture
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