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Site Compliance Head

3 months ago

Oxford, Oxfordshire, United Kingdom Moderna Therapeutics Full time

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.

The Site Compliance Head at Moderna's Harwell, UK site plays a pivotal role in implementing world-class quality system processes and operations. This leadership position is responsible for ensuring the highest level of compliance, providing strategic direction for the application of Moderna's Quality Management System (QMS) in support of internal manufacturing of commercially registered products. The role involves assessing and monitoring the health of the QMS for continuous improvement, leading cross-functionally to maintain a state of inspection readiness, and building a culture of quality across the site.

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.

Serving as a cross-functional quality leader and a GXP compliance subject matter expert.

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.

Evaluating business goals, identifying improvement opportunities, and applying problem-solving techniques to improve product quality and process effectiveness.

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. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.

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 status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at . (EEO/AAP Employer)

About Us

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission : To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision : To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling or emailing if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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