Quality Operational Planner

Job content

The Role

Reporting to Vice President International Quality, the Quality Operational Planner will be responsible for development, monitoring and reporting of International quality operation schedule. In close partnership with Supply Chain, the incumbent will ensure that E2E quality activities (internal and external) are planned and coordinated for on-time delivery of Moderna’s commitments and objectives.

The incumbent will coordinate timely execution of operational quality activities to support testing and release weekly plans. The incumbent will support promotion of performance and “customer service level” in quality activities execution. It provides an opportunity to operate in a highly collaborative role with matrix network of international and transversal partners, to ensure quality operations are planned as appropriate for production and regulatory plans delivery. Quality Operational Planner will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.

Here’s What You’ll Do

• Develop detailed E2E Quality Schedule for International Organization over the supply planning horizon, integrating quality activities (samples management, quality control, batch release, validation, distribution, documentation, audits, maintenance…) for on-time release and distribution of products.
• Be single point of contact for Supply Chain partners, ensuring plans are coordinated and maintained as appropriate.
• Coordinate consolidation and delivery of quality schedule in collaboration with SMEs network, including timely closure of Deviations/CAPAs/change controls when appropriate.
• Weekly-monthly measurement of performance, highlighting major risks, issues and required decisions.
• Prepare appropriate presentation materials to enable effective review of progress via Quality and Supply review processes.
• Maintain planning alignment with Moderna’s processes, in close collaboration with internal Quality subject matter experts.
• Use root cause analysis to identify systemic issues and lead resolution in partnership with appropriate experts, so that target performance levels are consistently achieved.
• Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing production and supply activities.
  

Here’s What You’ll Bring To The Table

• BS/BA in Supply Chain, Science or Economics/Finance with 8+ years’ experience.
• 3+ years’ experience in scheduling and coordinating complex activities in regulated environment, working across boundaries. Prior supply/production/quality Planner experience within Biotech, Pharma is advantageous.
• Fluency (written / spoken) in English – fluency in other languages is advantageous.
• Advanced Excel and PM tools skills, working experience with SAP/MRP.
• Scheduling/project management certification preferred (PMP, Greenbelt, APICS…).
• Organized with high structuring and analytical skills.
• Demonstrated usage of data to drive performance and decision making.
• Result-driven, customer and business focused – determined to deliver successful outcomes in effective way.
• Outstanding communication skills (verbal and written) to employee and leadership levels.
• Ability to conceptualize, analyze, plan, and manage multiple priorities in a fast-paced environment.
• Demonstrated ability to lead constructive partnership through influence (commit and deliver).
• Demonstrated ability to collaborate across boundaries (functional and cultural) and form effective working relationships with colleagues.
• Ability to be agile in a dynamic, cross-functional matrix environment.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.
  

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.