Manager QA, Commercial Drug Substance and
vor 6 Monaten
**The Role**:
Reporting to the Director, Quality Assurance Commercial Drug Substance the Manager QA will support Quality improvement initiatives, ensure robust processes and systems are implemented across Moderna commercial Drug Substance operations, and help ensure consistent maintenance of the Drug Substance platform. The incumbent will provide oversight in the implementation of Technology Transfers, New Products, Variants, and processes at internal and external manufacturing sites for commercial Drug Substance. Tasks may include oversight of Drug Substance and testing activities through review and approval of cGMP documentation including: Policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPAs, and change controls. This individual will be an integral partner for the implementation of Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.
**Here’s What You’ll Do**:
Provide oversight in the implementation of Technology Transfers, New Products, variants, and processes at internal and external manufacturing sites for commercial Drug Substance.
Provide Quality support to new site projects in close collaboration with the global Resilience project and local site teams.
Review and approve policies, SOPS, quality agreements, batch records, and ensure timely documentation, notification/escalation, and resolution of any issues and nonconformities.
Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls, design documents, master plans, and risk assessments).
Support quality investigations and manage CAPA (corrective and preventative actions).
Review and coordinate approval of platform changes made to the manufacturing, testing, and control processes.
Review and approve method, equipment, and process validation protocols and reports to ensure compliance with approved acceptance criteria.
Review as needed batch records, testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements, and internal policies and procedures.
Manage New Product Introduction by building a network between Drug Substance sites and the Drug Product platforms.
Coordinate alignment between Drug substances sites (internally or CMOs) for complex deviations, transversal CAPA, HA commitment etc. or Drug Products sites (internally or CMOs).
**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 5-8 years.
Working knowledge of relevant regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.
Experience in operations and manufacturing and testing within biotechnology industry.
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.
Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
Ability to navigate through ambiguity and rapid growth and adapt to change.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recogn
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