Sr. Manager, Technical Development Quality Assurance

The Role

Reporting to the Director of Technical Development Quality Assurance, the Sr. Manager Technical Development Quality Assurance will play a pivotal role in ensuring the quality and compliance of Moderna’s CMC development programs from early clinical stages through to commercialization. This individual contributor position involves closely working with the Technical Development teams to implement and maintain quality engagement that aligns with both internal and external phase-appropriate requirements.

Here’s What You’ll Do

• Provide Quality Assurance oversight throughout the technical development phases of process development, as applicable, ensuring all activities comply with internal quality standards and best practices.

• Evaluate and monitor the integration of quality assurance in the technical development processes to ensure end products are fit for purpose and meet predetermined quality specifications.

• Collaborate on designing and executing robust quality systems that improve process reliability, ensuring consistent, high-quality outputs.

• Work directly with the Technical Development teams to understand their quality needs and challenges. Assist in embedding quality assurance practices into daily operations and project workflows.

• Establish key quality metrics for technical development projects to measure process efficiency, product consistency, and compliance with quality benchmarks.

• Lead targeted quality improvement projects to address critical issues, enhancing system effectiveness and compliance.

• Recommend and implement enhancements to quality systems and processes based on thorough analysis and collaboration with technical teams and Quality Systems business owners.

• Lead quality assurance reviews and approvals of technical documentation, including protocols, reports, procedural documents, and risk assessments.

• Verify quality data and approve development reports and process analytics, ensuring rigorous quality standards are maintained.

• Facilitate cross-departmental initiatives to foster a culture of quality across the organization.

• Develop and conduct training sessions for the Technical Development team and stakeholders, focusing on quality assurance best practices, new technologies, and continuous process improvements.

• Partner with the Digital team to identify and implement digital tools and solutions that enhance process efficiencies and data management.

• Ensure that quality planning is proactive, comprehensive, and aligned with the overall strategic goals of the organization.

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

• Bachelor’s degree in a scientific/engineering discipline required with applied pharmaceutical industry experience of 5 years; 3 years with MS.

• Proven experience in quality assurance, specifically within drug product development, clinical, and commercial phases of pharmaceutical products.

• Demonstrated understanding of GxP regulations and quality management systems applicable to pharmaceutical development and manufacturing.

• Experience with quality system design, implementation, and oversight in a pharmaceutical setting.

• Exceptional written and oral communication and willingness to share knowledge and lessons learned.

• Strong analytical and problem-solving skills to effectively address and ameliorate quality issues.

• Excellent communication and interpersonal skills to effectively interact with cross-functional teams and facilitate training and development.

• Ability to lead quality improvement initiatives and manage projects independently.

• Proficient in data analysis and the use of digital tools to enhance quality processes.

• 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 h