Associate Director, Global Qc Digital

Vor 3 Tagen

Basel, Schweiz Moderna Vollzeit

**The Role**:
This position is part of Moderna’s Global Quality Control team responsible for GMP QC operations globally. The role will be responsible for building the digital capabilities (systems/processes/people) for QC and AS&T teams, increasing the digital maturity and integration between the different laboratories, and enabling greater operational efficiencies, compliance and QC data analytics and insights.

This role will collaborate closely with the QC and AS&T business teams and with digital teams to develop strategy, executable plans and projects to deliver the future vision of Moderna QC Laboratories.

**Here’s What You’ll Do**:
In this highly visible role as the Global QC Digital and Lab Informatics Business Lead you will drive the strategy, roadmap, customer demand management, people management, project management and solution development for the all the operations networks. In collaboration with the local QC Digital leads, business and digital partners, you will develop strategies and actionable plans that maximize the business value from the use of our Lab Systems portfolio (e.g: LIMS, LES, CDS, etc) ensuring efficient, compliant and data centric labs.

In additional the role will drive automation, data analytics and building capabilities for the labs to deliver highly digitalized platform, enhancing the ability for the labs to integrate and automate process, people and data. Enabling a data centric and intelligent lab environment that can step towards a predictive horizon.

**Key Responsibilities**:

- Responsible to develop, drive and audit the implementation of the Global Lab digitalization and automation strategy throughout the Moderna QC network.
- Responsible for the selection, design, deployment and roll-out of global standards for the QC operations network, in collaboration with local QC digital leads and digital teams.
- Lead the effort to ensure operational functionality of the Lab systems standard/s as well as compliance to cGxP, in collaboration with Sites leadership teams, Global Quality Assurance and Digital (security and infrastructure).
- Leads, manages, coaches, motivates, and guides matrix teams of highly skilled experts.
- Establish and manage the Lab informatics CoE enabling capabilities, standards, governance framework and portfolio management.
- Act as a global system owner and design authority for core enterprise QC Laboratory Systems and data platforms.
- Works with business teams to deepen use of analytics to deliver enhanced business insights for QC data, build dashboards, develop, and support lab informatics/statistics across QC processes.
- Partner with Quality Function and Digital to maximize scalability of solutions.
- Works with Digital/IT to continually strengthen data integrity across all analytical chemistry, bioassay, and microbiological laboratories world-wide.
- May own/coordinate Local/Global Change Controls related to Digital initiatives.
- Drive and coordinate global deployment of the standard across sites as well as deployment of upgrades, patches, and changes.
- Able to collaborate and communicate with a variety of stakeholders, ensuring that all stakeholders have appropriate information in a timely manner.
- Perform other duties as assigned.

**Here’s What You’ll Bring to the Table**:

- Degree in chemistry, biotechnology or equivalent, with minimum 15 years’ experience in the pharma/biotech. Industries, with good knowledge spanning from development to manufacturing.
- Experience in analytical chemistry and QC laboratory operations and processes within the pharmaceutical or biotechnology.
- Extensive experience in modernizing and digitalizing QC laboratories from strategy creation, development, and deployment at scale (LIMS, CDS, Planning, SDMS).
- Strong knowledge of laboratory systems standards for GxP systems, software and system development life cycle and management.
- Knowledgeable in laboratory technology and automation trends (robotics, integrated quality and compliance, digital worker - guided method execution, instrument integration) and implementation.
- Working knowledge on broad aspects of digitalization, data analytics and visualization and statistical tools (e.g. Cloud Services and infrastructure, Data Warehousing, SQL, Python, Tableau/Spotfire, Statistica/JMP, etc.).
- Excellent Business Partnering skills and ability to collaborate with customers and cross functional teams to deliver superior business outcomes.
- Strong influencing, leadership and people management skills, inspiring and empowering leadership style.
- Highly customer-focused, with demonstrable stakeholder management experience and passionate about delivering high quality innovative solutions and services that meet business needs, which are readily scalable.
- A proven track record of running high performing environments, including virtual teams.
- Innovative, responsible, and reliable with a highly developed strategic mindset.
- Able to contribute at a functi

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