The Role Moderna is looking for curious, engaged leaders with an appetite to solve complex problems, drive significant outcomes and deliver innovative solutions as part of the teams producing drug substance and critical raw materials. Our rapid growth has afforded us an extraordinary opportunity to transform the way medicines are manufactured and delivered globally. To better enable this growth, we are looking for a motivated and agile leader with CMC expertise in one or more functional areas to be the Director, Quality Assurance. The Director will be part of a cohesive team responsible for materials manufactured via chemical synthesis as well as purchased raw materials. They will provide quality oversight and expertise to both internal and external manufacturing operations in order to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience with the application of cGMPs by product type, and over the product lifecycle from early stage clinical to commercial use. Strong decision-making skills, independent thinking, and the ability to develop a high-performing team will be paramount. They will interact fluidly with cross-functional peers and leaders in Manufacturing Operations, Technical Development, Quality Control, and the broader global Quality organization. Here’s What You’ll Do Ensure quality systems and processes are designed and implemented to support the manufacturing of critical raw materials in alignment with relevant regulatory requirements. Lead the QA functional organization that includes the following capabilities: QA floor support, Batch Production Records, Deviations and Change Management, CMO Oversight, Technology Transfers, and Batch Release. Operate as the Site Quality Leader for the internal manufacturing of chemistry-based critical raw materials. This includes ensuring quality objectives are implemented, understood, and maintained at all levels of the organization. Develop short and long-term plans to achieve both quality and business objectives. Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement. Responsible to assure that there are no significant interruptions to the business due to quality or compliance issues. Design, build, and continuously develop a high-functioning quality assurance operations teams in connection with company’s strategic goals, quality objectives and to scale with Moderna operations. Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Interface directly with FDA, EMA and other regulatory authorities and ensure the company is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities. Develop resource strategies, allocate budget, staff, tools, and specialized support necessary for efficient operations. Here’s What You’ll Need (Minimum Qualifications) BS Degree in Science-field (e.g., Engineering, Chemistry, Pharmacy) or equivalent combination of education and experience 12 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Test Methods, Manufacturing and process engineering. 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! 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. About Moderna 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-PL1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home