Business Process Manager, Validation Solution Digital Quality

The Role

In this role, you will be responsible for the process management and delivery of projects related with Validation & testing platforms & tools. Also includes day to day operational support, maintenance, and continuous improvement of our global validation system and testing tools. Reporting to the Director QMS Delivery Lead, you will help setting up the company’s validation standards in partnership with business stakeholders and will support the business on projects related to the validation system.

Moderna is a cloud-first company, and this role will balance building strong foundations, with implementing innovative new solutions that drive business value. With our progress towards commercialization, this position will play a key role partnering with our business stakeholders to enable our systems and processes for long term success.

Here’s What You’ll Do

• Drive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise.

• Contribute to the continuous improvement of the validation solutions & tools and is the key entry point for enhancement requests and system changes.

• Lead technical projects focusing on expanding capabilities of the electronic validation management system

• Provide SME support as process manager and administrator for current Validation Solution (Kneat) & Testing Tool (Tosca) and project management tools (e.g. Jira), including but not limited to:

  • Enhancements, Configuration, technical and operation support

  • Administrator support to operate systems including role management, access management and data management

  • Documentation review & updates, Metrics and Dashboard reporting, guidance, & training to users on the application

• Perform evaluation and prioritization of system enhancements and capabilities to ensure efficient usage and maintenance

• Provide technical design insight within the applications, maintain, and improve data model and integrations between systems

• Perform validation activities related to implementation and on-going support

• Generate standard and custom reports based on business and compliance needs

• Support planned and unplanned inspections/audits

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

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

• 5+ years of experience implementing and maintaining technology to support compliance processes in a regulated biotech or Pharma company

• Strong Experience with electronic validation management systems (Kneat, qTest, ALM etc.), testing tools (Tosca), or similar technologies

• Strong experience with validation solution strategic delivery

• Experience with validation policies and GxP documentation for validation systems / testing platforms

• Prior working experience with computer systems validation practices (GAMP)

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

• Experience with system administration of Kneat Validation System

• Experience with Jira

• API, data report development and systems integration

• Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions

• Understanding of industry technology trends in document management and validation management

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer system validation and data integrity

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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Vol