Manager, Quality Assurance

Vor 4 Tagen

Basel, Schweiz Moderna Vollzeit

The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.

**Here's What You’ll Do**:Your key responsibilities will be**:
Providing network quality assurance support across Moderna's CMO Drug Product QA teams, focusing on process efficiency and maintaining the highest standards of quality.

Overseeing quality aspects of change controls, managing the eQMS workflow, and ensuring proper notification and follow-up on implementations.

Conducting GMP Confirmation for Drug Product CMO batches, including batch record review, eQMS documentation checks, and SAP release steps.

**Your responsibilities will also include**:
Reviewing and approving deviations associated with filling, packaging, and out-of-specification results, and chairing Material Review Boards for critical deviations.

Supporting New Product Introductions, including but not limited to: approving change controls, reviewing and approving CMO and Moderna Bills of Materials (BOMs), executed batch records, and participating in PPQ deviations review.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**Pursue options in parallel**: This mindset is crucial as it enables the role to manage multiple tasks effectively, ensuring flexibility and a proactive approach to problem-solving.

**Act with urgency**: Understanding the critical nature of timelines in the pharmaceutical industry, this mindset will guide you to prioritize tasks effectively to meet stringent deadlines.

Here’s What You’ll Need (Minimum Qualifications)

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree preferred.

5-10 years of experience in quality assurance within the pharmaceutical or biotechnology industry, specifically in batch oversight and CMO management.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

Demonstrated experience with deviation management, change control processes, and regulatory compliance.

Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar quality assurance certifications are highly desirable.

Training in Veeva Quality Management System and SAP is preferred.

Excellent organizational and leadership skills.

Strong analytical and problem-solving abilities.

Effective communication skills, both written and verbal.

Ability to work cross-functionally and collaborate with internal and external stakeholders.

A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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 recognized as a Science Magazine Top Biopharma Employer, a Fast Company Be

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