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Director, Product Quality Lead
vor 4 Monaten
**The Role**:
Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks. Ensures quality management of products and processes lifecycle, leading improvement, and alignment with current regulatory expectations.
**Here’s What You’ll Do**:
Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Moderna’s vaccines and therapeutics inclusive of combination product design controls
Interface in a matrix environment with drug and combination product design and development teams to develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical transfer and Control Strategy
Ensure significant Quality risks are escalated and mitigated in a timely manner
Provide quality support for significant changes and issue management (Deviations/CAPAs) across Moderna’s internal and external manufacturing and testing sites
Contribute to improvement and harmonization initiatives across Global Quality Operations in line with current Regulatory expectations.
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 of new and emerging technologies to ensure quality and compliance frameworks are established
In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes
**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 15-20 years; 10-15 with MS.
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
Knowledge in design controls, risk management, and quality system requirements.
Working knowledge of control charts and statistics applied to process validation and data trending using statistical programs and software (e.g, JMP, Looker, Statistica, Spotfire)
Experience in computerized systems, automation, manufacturing, and testing within biotechnology industry is a plus.
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 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
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 is a smoke-free, alcohol-free and drug-free work environment.
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