Reporting to the Director of Quality Logistics within Moderna’s Research & Development Quality (RDQ) organization, located at the Moderna Headquarters in Cambridge, MA, the Associate Director of RDQ Quality Logistics, will contribute to growing and shaping Moderna’s R&D Quality function focusing on a training and competencies program for RDQ staff. The Associate Director, Quality Logistics will be responsible for development, execution and maintenance of a comprehensive R&D GxP cross-functional training and competencies program for RDQ staff. The Associate Director, Quality Logistics will contribute to creating a quality culture within Moderna and drive toward a sustained state of inspection readiness.
Here’s What You’ll Do:
Assist the Director, Quality Logistics in development of the RDQ Annual Audit Plan and periodic review, updates and maintenance of the Plan
Assist the Director, Quality Logistics in liaising with other RDQ functions to build the RDQ Audit Schedule and ensure audits are resourced appropriately
Build, execute and maintain a RDQ cross-functional training program and skills matrix designed to monitor and track RDQ staff competencies and development of cross-functional GxP capabilities
Contribute to the development of quality and compliance strategies across the RDQ organization
Provide input, as applicable to development of RDQ and R&D policies and procedures
Participate in regulatory authority inspections, as necessary, and provide input and review of responses to inspection observations and regulatory agency questions resulting from these inspections
Actively participate in implementing new strategies, innovation and solutions to the RDQ program
Contribute to the continuing development of a quality culture at Moderna.
Here’s What You’ll Bring to the Table:
BS/BA with a minimum of 8 to 10 years’ experience or MS with 5 to 8 years’ experience in pharmaceutical / biotech / vaccines industry
Strong knowledge of relevant FDA, EU, ICH GCP guidelines, regulations.
Ability to build, execute and maintain a training matrix and curriculum for GCP, GVP, GLP and GcLP quality staff that includes a program for assessing staff competencies.
Knowledge / experience developing annual audit plans and managing a consolidated audit schedule for all GCP, GVP, GLP, GcLP and CSV audit types is desired.
Strong interpersonal skills and ability to interact effectively with all levels within the organization.
Experience in supporting regulatory authority inspections and developing responses to regulatory authority inspection findings is a plus.
Ability to solve complex problems taking a broad perspective to identify innovative solutions.
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Knowledge working with digital systems in the audit environment is a plus.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-LG1