Sr. Business Process Manager, Digital Quality

vor 7 Monaten

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.

In this dynamic and pivotal position, you will report directly to the Director of Digital Quality. Your primary focus will be on designing, deploying, and managing our expanding portfolio of digital quality management systems that crucially support both Quality and batch release processes. This role is instrumental in shaping and delivering the long-term strategic vision for our Quality QMS Digital roadmap.

Here’s What You’ll Do

**Your key responsibilities will be**:
**Strategic System Design and Deployment**: You'll lead the design and deployment of our digital quality management systems, aligning them with the Quality QMS Digital roadmap. This involves strategic planning, system architecture development, and integration of technological innovations.

**Operational Excellence and Project Management**: Drive the execution of complex digital projects by identifying risks, formulating mitigation strategies, and managing timelines. Ensure projects align with both technical and business aspects, achieving desired outcomes efficiently.

**Your responsibilities will also include**:
**Mentorship and Team Development**: Mentor and support a team of business analysts and software engineers, fostering an environment of growth and innovation. Guide your team in maintaining our electronic quality management system, Veeva Quality, ensuring it meets the evolving needs of the business.

**Innovation and System Integration**: Collaborate with digital stakeholders to integrate key systems into the quality management framework effectively. Explore opportunities for automation and the incorporation of artificial intelligence to enhance system capabilities and user experience.

**Audit and Inspection Readiness**: Maintain inspection readiness by adhering to internal quality policies and participating in audits as the digital quality expert. Ensure all processes and systems are compliant with regulatory standards.

**Stakeholder Engagement and Continuous Improvement**: Engage with various stakeholders within the Quality domain to support and drive digital quality strategies. Continuously seek opportunities to optimize processes and improve system performance to support sustainable commercial operations.

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

Bachelor’s degree in science, technology, or another relevant academic discipline

8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company.

Experience with GAMP and GxP compliance regulations

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

Strong understanding of batch release, quality management workflows, and related processes

Demonstrated experience defining, scoping, and managing technology initiatives ; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.

**Proficient in relevant project management software**: Smartsheet, Excel, PowerPoint, Word, OneNote, MS Teams, etc. in addition to general knowledge with shared work environments

People-oriented

Extremely organized.

Creative/innovative/problem solver that actively drives progress.

Passion for people management and development in matrix teams

Outstanding communication, presentation, and writing skills and ability to tailor messaging to audience.

Ability to manage multiple projects in a fast-paced environment.

Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

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:
Quali

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