Lab Compliance Manager

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 .
Moderna is in search of a highly motivated and experienced Sr. Manager of Laboratory Compliance to ensure our laboratories comply with GCLP guidelines and other applicable regulatory requirements. This crucial role involves supporting the development, implementation, and maintenance of processes and procedures that ensure the integrity and quality of laboratory data. We value communication skills, as this role requires effective articulation of ideas, attentive listening, and engagement with a diverse range of stakeholders.
Here's What You’ll Do:
Your key responsibilities will be:

• Leading the management of non-conformances, including root cause analysis and resolution of Quality Events (QE).
• Spearheading the internal audit program and driving continuous improvement initiatives.
• Managing document control, including the centralization of document storage and maintenance of training records.
• Assisting in the creation and revision of SOPs, ensuring adherence to ALCOA+ principles.
• Compiling and analyzing Quality metrics to inform decision-making and process improvements.
  

Your responsibilities will also include:

• Supporting laboratory teams across end-to-end operations for compliance and quality assurance.
• Developing strong business relationships with cross-functional teams to enhance laboratory compliance efforts.
• Participating in external audits and regulatory inspections to ensure adherence to all relevant standards.
  

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

• Pursue options in parallel: Ability to manage multiple aspects of laboratory compliance simultaneously, ensuring thoroughness and efficiency in meeting regulatory standards.
• Accept risk: Taking calculated risks to improve laboratory operations and compliance, while always prioritizing safety and quality.
  

Here’s What You’ll Bring to the Table:

• Minimum of 5 years of relevant experience required in regulated laboratory environment with 2 years of supervisor or management experience within drug development at pharmaceutical, biotech or CRO.
• Masters/ Bachelor degree in a scientific discipline, such as Biology, Chemistry, or related field
• Knowledge in clinical sciences and technology is required.
• Extensive experience in laboratory operations and compliance within a regulated environment, e.g., ISO9001/15189 GLP, GCP.
• Proven track record of leading quality initiatives and internal audits.
• Strong understanding of regulatory requirements and quality management systems.
• Exceptional leadership skills and the ability to drive cross-functional collaboration.
• Excellent communication skills, both written and verbal, with the ability to influence and engage stakeholders at all levels.
• Previous experience leading, reviewing, managing governance documents, access and archiving to vault highly preferred.
• Meticulous attention to detail, organizational ability, clinical judgement, and good communication skills
• High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail
  

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 modernatx.com/careers 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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