Director, Digital Quality Resilience and INT Lead

The Role

Reporting to the Executive Director of Digital Quality, the Digital Quality Resilience and INT lead will be responsible for the deployment and continuous improvement of our digital platform systems/instruments supporting our Global Quality Control.

Moderna is a cloud-first company, and this role will balance building strong foundations, with implementing innovative new solutions that drive business value. This position will play a key role partnering with Quality Control stakeholders and peers to enable our systems and processes.  

Under Programs Resilience and INT, Moderna is expanding manufacturing & laboratory operations to additional  global sites such as Australia (Clayton), Canada (Laval) and the UK(Harwell). Digital Quality systems (Instruments, Enterprise & Local Systems, etc.) are required to be extended, functional and qualified for the Operational Readiness of each site.

Who You Are:

You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency.  You thrive in a fast-paced environment and are comfortable rolling up your sleeves – if a process doesn’t exist yet, you define it.

Here’s What You’ll Do

• Lead and manage a team of engineers designing and implementing the digital quality systems and instruments that will be deployed at the global Moderna Laboratories/Sites (Norwood, Madrid, Laval, Clayton etc.)

• For Project Resilience and INT lead the execution of the Digital Quality workstream proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines. Ensure that the in scope digital systems for each site deployed on time to support site qualification and method transfer to QC. Engage with the system owners to ensure that an appropriate support structure is in place to support each system at each site.

• Lead the execution of complex, integrated projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines. 

• Partner closely with key business stakeholders to understand their processes and deploy solutions to measurably support the business need. 

• Engage with digital quality team members and system owners in the US to ensure to maintain consistency in the systems or instruments while meeting the needs of the local business stakeholders.

• As a member of the Digital Quality LT work partner with peers to lead the DQ team, to drive the success of ongoing efforts and implement improvement projects to meet evolving business needs. 

• Work with and provide input to digital management to develop and maintain a multi-year roadmap of key capabilities aligned with business strategy. 

• As required participate with digital leadership teams to implement efforts and improvement projects to meet evolving business needs. 

• Ensure GMP compliance is prioritized in the design, delivery, and maintenance of all systems. 

• Serve as a change agent to engage and educate the business owners on the capability and functionality of digital solutions.

• Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.  

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

• Bachelor’s degree or equivalent in science, engineering or computer science, MBA or PhD is a plus.  

• 8 - 10 years’ experience designing and implementing systems in the laboratory (ideally experience with instrument deployment, LIMS, CDS etc.) working in a GMP environment

• Compliance focused mindset

• Strong understanding of core laboratory system workflows 

• Strong understanding of laboratory systems including data integrity regulations, instrument integration and laboratory digital workflow optimization 

• Ability to adapt to a fast changing, startup like environment.

• Experience in defining, scoping, and managing technology initiatives.

• Strong knowledge GAMP and GXP compliance regulations 

• Ability to effectively communicate with all levels within the organization.

• Ability to lead and motivate teams to reach a common goal.

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

• Creative/innovative/problem solver that actively drives progress

• Ability to work independently and make sound and timely decision to achieve expected results

• Strong understanding of core laboratory systems, related processes, and quality management workflows

• Strong interpersonal skills with the ability to build succ