The Manager of R&D Quality & Compliance will proactively promote compliance to Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams compliance guidance support related to GCP global regulations and guidelines. Additionally, the Manager applies established knowledge and experience with GCP regulations, guidelines and local legislation to the auditing process to identify compliance issues associated with the conduct of clinical trials. The Manager should have a solid knowledge of US FDA and international regulations, and of ICH guidelines. The appointee will also be responsible to partner with study teams to create a quality culture within Moderna and help reach a sustained state of inspection readiness.
Here's What You'll Do
Participate in the development of clinical quality assurance strategies for the support of global clinical trials.
Partner closely with members of the Clinical and Research Development groups to support the successful and compliant execution of clinical trials.
Work closely with clinical study team members to provide proactive guidance to complex issues.
Provide input in the development of the Annual Audit Plan and create and maintain study-specific audit plans.
Plan, execute and report GCP investigator site, study, system/process, and vendor audits, as necessary, and work with Moderna staff to ensure the proposed corrective and preventative actions received from the auditees are appropriate and implemented.
Participate in post-audit meetings to present/discuss audit findings.
Identify and report systematic issues and areas for improvement with the assistance of management, as needed.
Participate in regulatory authority inspections, as necessary.
Serve as a trainer and mentor to auditor trainees.
Contribute in the continuing development of a quality culture at Moderna.
Additional duties as may be assigned from time to time
Approximately 30% travel
Here's What You'll Need (Minimum Qualifications)
BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
Here's What You'll Bring to the Table (Preferred Qualifications)
Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
Experience working with CROs, vendors, and relationship management preferred.
Prior experience managing individuals preferred.
Vaccine clinical trials experience is a plus.
Excellent auditing skills and ability to communicate significant observations to Auditees in a sound and factual manner.
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to work independently and within a team environment.
Strong communication and presentation skills, verbal and written.
Ability to influence and negotiate effective solutions.
Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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)
