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The Role: Reporting to the Director of Research & Development Quality (RDQ), located at the Moderna Headquarters in Cambridge, MA, the Associate Director of Quality Management System (QMS) Quality, will be a key contributor in growing and shaping Moderna's R&D Quality function focusing on contributing to building a highly functioning team of R&D quality professionals. This leadership role will provide oversight, strategic direction, management support and guidance for building and maintaining a function within the RDQ organization that is responsible for quality oversight and support of (i) R&D Quality Management System, (ii) GCP/GLP/GVP activities conducted by Moderna and its service providers, (iii) providing compliance support to the Moderna R&D (GCP/GLP/GPV) organization including procedural document quality review, (iv) supporting Regulatory Authority inspections as they relate to Moderna's R&D QMS and (v) supporting the appropriate integration of the R&D QMS with the Moderna Global QMS. The appointee will also be responsible to partner with the R&D organization to create a quality culture within Moderna and drive toward a sustained state of inspection readiness. Here's What You'll Do: * Participate in the establishment and support of the formalized R&D QMS. * Collaborating with R&D colleagues to assess/support the state of the R&D QMS by evaluating the major elements for both current state and as part of the ongoing assessment of the QMS for continuous improvement. * Provide direction and support for the R&D QMS Procedural Document Management, LMS Management, Training program development and management, and Metrics and Reporting functions. * Work with the RDQ-QMS metrics role to collect and evaluate R&D key quality metrics in an ongoing fashion for quality management reporting. * Provide quality consultant review/support for procedural document functional content and Lean SOP structure to R&D colleagues. * Establish and maintain policies and procedures for the GCP/GLP/GPV/CSV QA functions, as well as provide guidance/review/approval of policies and procedures within these functional areas. * Provide active R&D representation/participation in the Global QMS organization to ensure appropriate R&D GxP integration. * Actively participate as a key member of the inspection team for health authority inspections of Moderna as it relates to the R&D QMS (procedural documents, training, issue management, risk management) systems. * Provide expert guidance and direction in the development of responses to Regulatory Authority inspection findings for inspections of Moderna's QMS. * Contribute to the continuing development of a quality culture at Moderna. Here's What You'll Bring to the Table: * BS/BA, MS or PhD and a minimum of 12-15, 8-10, 10 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization. * Strong knowledge of relevant FDA, EU, ICH GCP guidelines. * Knowledge of relevant FDA, EU, ICH guidance for GVP, CSV and GLP. * Experience working with CROs, vendors, and relationship management. * Strong interpersonal skills and ability to interact effectively with all levels within the organization. * 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. 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 concie To view the full job description, click here</>