Site Compliance Head
6 months ago
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.
Moderna's strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK. We're looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all.
Here’s What You’ll Do
**Your key responsibilities will be**:
Implementing Moderna’s overall Quality Management System (QMS), quality manual, policies, and procedures at the site.
Overseeing the performance and effectiveness of QMS programs, including Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.
Maintaining the site in a constant state of inspection readiness, hosting inspections, and engaging directly with Health Authority inspectors.
**Your responsibilities will also include**:
Leading Management review meetings and monitoring the state of control of Moderna’s QMS at the site.
Serving as the site compliance representative on Global Compliance Councils.
Working collaboratively with the Compliance organizations across Global and the sites, along with the digital team, to drive effective and efficient processes supported with digital e-systems.
**The key Moderna Mindsets you’ll need to succeed in the role**:
**We behave like owners**: Taking ownership of the quality and compliance of our Harwell site, ensuring that every action reflects our commitment to excellence.
**We pivot fearlessly**: Embracing the dynamic nature of compliance and quality management, ready to adapt and respond to new data or regulations to maintain our high standards.
**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering
Applied Quality industry experience of 10+ years.
Demonstrated experience with Pharmaceutical Quality Systems.
Inspection experience preferred.
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. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran st
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