Description:
Moderna’s Digital GMP Operations Excellence team leads the development, deployment, and support of critical GMP applications across our global network of manufacturing plants and laboratories. Using cutting-edge technologies and robotics, the team drives a Digital-First Manufacturing mindset.
We are seeking an experienced Digital IT Site Lead to oversee and enhance digital manufacturing systems at our GMP manufacturing site in Clayton. This role combines technical expertise in systems like ERP, MES, PCS, and LIMS with operational experience in IT management and compliance, ensuring the site’s readiness for regulatory audits. You will champion Clayton's digital needs, aligning them with Moderna’s broader digital strategy while leading a talented team in a transformative manufacturing environment.
Here's What You’ll Do:
Your key responsibilities will be:
Leadership & Team Development:
- Lead, mentor, and develop a team of IT professionals, fostering innovation and alignment with Moderna’s core mindsets.
- Ensure the team is skilled and equipped to deliver excellence in a GMP manufacturing environment.
Digital Operations Management:
- Oversee daily IT operations at the site, ensuring system reliability, compliance, and performance.
- Drive the implementation of cutting-edge technologies to enhance manufacturing processes.
Digital Strategy & Execution:
- Develop and execute Clayton's digital strategy in alignment with Moderna’s global roadmap.
- Contribute to Industry 4.0 initiatives, incorporating IoT, AI, and advanced analytics.
Your responsibilities will also include:
System Management & Compliance:
- Manage ERP, MES, PCS, and LIMS systems while ensuring compliance with GMP, FDA, TGA, and similar regulations.
- Implement and maintain robust cybersecurity measures.
Project Leadership:
- Lead digital transformation projects from initiation to completion, ensuring seamless integration and change management.
Collaboration:
- Partner with site leadership and Digital Core to align objectives and deliver digital solutions tailored to manufacturing needs.
- Engage with vendors to optimize IT services and system performance.
Continuous Improvement:
- Promote Lean, Six Sigma, and other methodologies to enhance IT systems and processes.
- Share best practices across Moderna’s network.
Here’s What You’ll Need (Minimum Qualifications) :
- Bachelor’s Degree in Information Technology, Computer Science, Engineering, or a related field. A Master’s degree or relevant certifications (e.g., PMP, ITIL, etc.) is a plus.
- Knowledge of ISA 95 Standard.
- 8+ years of experience in IT, with at least 3-5 years in a leadership role managing IT in a manufacturing or GMP-regulated environment.
- Strong understanding of GMP, FDA, TGA regulations, and other relevant compliance standards in pharmaceutical or biotech manufacturing.
- Proven experience managing and supporting digital platforms such as MES, PCS, ERP, LIMS, and SCADA in a production setting.
- Experience with cloud computing, cybersecurity, and IT infrastructure management in a manufacturing environment.
- Demonstrated experience with digital transformation projects, including the implementation of Industry 4.0 technologies.
- Strong leadership and interpersonal skills with the ability to influence and work collaboratively across all levels of the organization.
- Excellent problem-solving, project management, and decision-making skills.
- Strong communication skills with the ability to present technical information to non-technical stakeholders.
- This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.