Reporting to the Senior Director, Global Quality Operations, the Director, Global Quality CMC Operations will lead the execution of fit-for-purpose Quality System Elements for complex Global Product Lifecycle Management events. He/she will be responsible for collaborating with internal, external, and international Quality to lead and drive harmonization of initiatives across Global Quality Operations including change controls, deviations, CAPAs, and product disposition. The individual will partner cross-functionally with Technical Development, Manufacturing Sciences & Technology, Manufacturing, Quality Control, Facilities, Supply Chain, Digital, and Regulatory to ensure robust processes and systems are implemented and maintained in support of Modernas CMC programs. In collaboration with the Global Quality Systems and Compliance team, this individual will support and operationalize enhancements of Modernas Global Quality Management System. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
Heres What Youll Do:
Act as global Quality representative in cross-functional forums to ensure Modernas internal and external manufacturing and testing facilities are consistently evaluating and implementing processes and systems for adherence to the overall validated state and license requirements
Provide quality support and oversight to the functional lines for significant changes and issue management (Deviations/CAPAs), ensuring appropriate implementation of change and CAPA actions across Modernas internal and external manufacturing and testing sites
Facilitate the Global Change Review Board comprised of cross-functional Senior Leadership
Provides Quality oversight for New Product Introduction including planning of global product launches and quality approval and implementation of Finished Product artwork/labels
In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System
In collaboration with the site quality operations teams establish consistent disposition practices worldwide and drive continuous improvement of the lot disposition system.
In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes
Heres What Youll Bring to the Table:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-20 years; 10-15 with MS.
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.
Practical experience with Quality Risk Management lifecycle.
Ability to interact effectively with all levels of personnel within the organization.
Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
Outstanding communication skills (verbal and written).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A digital first and curious mindset that allows you to constantly learn and challenge the status quo.
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 winter shut down
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.
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 persons 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.