The RoleIn this role, reporting to the Director of R&D Clinical Quality, you will: (i) Serve as a key contributor to Moderna's R&D Quality Function by being an integral part of a highly effective team of GCP quality professionals; (ii) Provide proactive compliance guidance related to global GCP regulations and guidelines through robust Quality Program Management, Issue Management, and CAPA Management; (iii) Conduct audits, investigations, and associated CAPAs, utilizing established knowledge and experience with GCP regulations, guidelines, and local legislation to identify compliance issues in the conduct of clinical trials. Furthermore, the Associate Director will be responsible for implementing programs and tools that proactively promote adherence to GCP regulations and guidelines. The appointee will also collaborate with study teams and business partners to establish a quality culture within Moderna and achieve a sustained state of inspection readiness.Here's What You'll DoContribute to the development of GCP clinical quality assurance strategies for the support of global clinical trials.Enhance the Issue Management and CAPA Management programs to eliminate redundancies and create a more streamlined process.Work in conjunction with the Director of R&D Quality on serious breach cases and research scientific misconduct incidents, ensuring that investigations, corrective and preventive actions, and documentation meet regulatory standards and demonstrate appropriate sponsor oversight.Plan, conduct, and report on GCP compliance of investigator sites, studies, systems, and vendors as needed, collaborating with Moderna staff to ensure that auditees' proposed corrective actions are suitable and carried out.Collaborate closely with members of the Clinical and Research Development teams to facilitate the successful and compliant execution of clinical trials.Act as the R&D Quality representative on program teams, offering proactive advice on clinical study matters to help maintain a continuous state of inspection readiness.Provide proactive guidance on complex issues to clinical team members.Participate in regulatory authority inspections as required and contribute to the preparation and review of responses to inspection findings and questions from regulatory agencies.Serve as a trainer and mentor to auditor trainees.Participate in compliance projects and initiatives.Contribute in the continuing development of a quality culture at Moderna.Additional duties as may be assigned from time to timeHere's What You'll Need (Minimum Qualifications)BS/BA, MS or PhD and a minimum of 12 years experience, respectively, in Biotech, Pharma or Clinical Research Organization.10+ years' experience in Clinical QA in a global environment.Here's What You'll Bring to the Table (Preferred Qualifications)Expert knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP regulations.Knowledge of relevant FDA, EU, ICH guidelines and regulations an advantage.Experience working with CROs, vendors, and relationship management preferred.Excellent auditing skills and ability to communicate significant observations to Principal Investigators, Senior Scientists, etc., in a sound and factual manner. Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.Strong leadership skills with ability to effectively organize and execute tasks.Ability to work both independently and in a team environment.Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.Excellent communication and presentation skills, both verbal and written.Ability to influence and negotiate effective solutions, excellent interpersonal skills.Ability to manage multiple projects in a fast-paced environment. A desire to make an impact as part of a high-growth, transformational company that isBold, 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince 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 peopleare 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 ****** . (EEO/AAP Employer) #LI-LG1-
