Director, Resilience QA Project Leader

vor 3 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Global Quality Head, Commercial Drug Substance, the Resilience QA Project Leader will be responsible for supporting the global deployment of platform DS manufacturing sites globally (Canada, Australia, and UK mínimally).

The Resilience QA Project Leader will serve as a core-team member in the establishment of common design and CQV standards, while establishing a global network of consultants able to support in-country execution. This leader will integrate the QA and QC global business units to establish the Operational Readiness strategy, including Quality Systems, and then partner with the in-country Site Quality Heads on implementation.

**Here’s What You’ll Do**:
During the project CQV phase, represent Commercial Drug Substance QA on the Site Activation Team

For sites that include drug product manufacturing, represent Commercial Drug Product QA

Lead the Quality project team consisting of Global Quality Systems and Compliance, Quality Control, Commercial Drug Substance QA, and Commercial Drug Product QA

Quality project team members will hardline report into their respective business units with dotted-line accountability to the Resilience QA Project Leader.

Lead the QA Validation global team

Provide QA input on facility and equipment design, as well as CQV strategies and documentation development

Establish and manage a QAV team, including CSQ, of FTEs and consultants able to support the on-time in-country execution

Develop the Quality Operational Readiness plan

**This plan should be inclusive of**: Quality Systems (SOPs, Site Master Plans), Quality Control, Training

The integrated plan should be project managed (Communicated to Quality stakeholders, risks identified and escalated)

Collaborate with the Site Quality Heads in-country on deployment

Travel routinely to Resilience sites to support on-site execution and ensure performance

**Here’s What You’ll Bring to the Table**:
Bachelor’s degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years.

Previous experience with Commissioning and Qualification

Previous experience leading a matrixed team, preferred

Previous experience working globally, preferred

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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