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
Here's What You'll Need (Minimum Qualifications)
- 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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- 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.
- 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.