Reporting to the Director, R&D GLP/GCLP Quality, located at the Moderna Headquarters in Cambridge, MA, the Manager of Good Laboratory Practice/Good Clinical Laboratory Practice (GLP/GCLP), applies established knowledge and experience in internal, in-process, study and vendor audits. The Manager should be familiar with global Health Authority Regulations including US FDA 21 CFR Part 58, any applicable GLP/GCLP international regulations, and GLP/GCLP guidance and is responsible for the oversight of Moderna Biomarker laboratory activities and associated bioanalytical analysis. The Manager will also partner with R&D to create a quality culture within Moderna, provide business support, process improvements and inspection support as needed. This position may interact with regulatory agencies and corporate partners during inspections and audits, and it may require minimal travel for auditing vendors.
Here's What You'll Do:
Participate and actively engage in strategic initiatives which require GLP quality support.
Provides continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to nonclinical and bioanalytical studies.
Review/audit study materials, data and reports associated with nonclinical, pharmacological and bioanalytical studies.
Plans, conducts and reports internal, in-process, study, and process audits.
Manages audit CAPAs and responses as per Moderna procedures.
Support regulatory agency inspections and vendor audits as needed.
Contribute in the continuing development of a quality culture at Moderna.
Additional duties as may be assigned from time to time
Here's What You'll Need (Minimum Qualifications):
BS/BA, or MS and a minimum of 8-10 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Here's What You'll Bring to the Table (Preferred Qualifications):
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP (understanding of regulatory guidelines for other countries a plus).
Practical knowledge of GLP/GCLP related audits activities and business standards.
Bioanalytical technology, including but not limited to LIMS, PCR, plate reader, and mass spectroscopy proficiency is highly desired.
Expertise with business office applications, word processing and spreadsheets.
Demonstrated knowledge and/or prior experience in Quality Assurance.
Outstanding communication skills (verbal and written)
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.
Relies on experience and judgment to plan and accomplish goals.
Excellent organizational skills and keen attention to detail.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Travel Requirements 20%
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
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.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
