Controlled Document Strategy & Execution Lead

The Role:

This is a strategic leadership role responsible for driving the design, management, and implementation of processes and controlled documents to ensure the organization operates in a proactive state of inspection readiness. The successful candidate will partner closely with the Head of Process Management, Training and Execution, as well as Clinical Compliance and Inspection Readiness, to deliver scalable solutions that strengthen compliance, streamline operations, and enable execution excellence.

The ideal candidate brings deep expertise in controlled document strategy and process management, combined with proven leadership skills to drive organizational transformation in a fast-paced and highly regulated environment. This leader will shape and execute strategy, oversee implementation, and foster a culture of quality, innovation, and continuous improvement across the organization.

• Lead the development, optimization, and enterprise-wide implementation of Clinical Development processes, controlled documents, and tools to deliver a prioritized pipeline of procedural improvements.

• Define and execute the controlled document development and rollout workflow, ensuring scalability and alignment with enterprise needs.

• Establish and manage a hybrid strategy framework with vendor partners for SOP list management, ownership, and trial-level implementation.

• Drive end-to-end process improvement for controlled documents in partnership with mPROVE, ensuring seamless intake through execution.

• Conduct SOP and process gap assessments across internal and external stakeholders; lead change management and implementation of solutions.

• Align with Compliance and Quality (QIs, QEs, CAPAs, Inspection Findings) to proactively address risks and strengthen inspection readiness.

• Develop and oversee digital solutions (e.g., Smartsheet, validated systems such as Please Review) to track, manage, and mitigate risks associated with controlled document development, training integration, and document versioning.

• Implement standardized controlled document templates and digital tools that enable clear ownership (Moderna/CRO/shared) and ensure audit readiness.

• Integrate SOP strategy with training management systems to ensure automated assignment, tracking, and compliance monitoring.

• Partner with training curriculum owners to validate structures, strengthen oversight, and ensure consistency across the enterprise.

• Define and track KPIs, deliverables, milestones, and timelines for controlled document development and roll‑out.

• Analyze systems and processes, providing recommendations for optimization or new solutions to enhance compliance and efficiency.

• Embed a culture of continuous improvement, identifying opportunities to reduce cost and cycle time while maintaining quality and regulatory rigor.

• Provide regular updates through governance forums, leadership reviews, and cross‑functional town halls.

• BA/BS required; advanced degree preferred (or equivalent experience)

• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, or in a similar regulated environment, with demonstrated leadership in training program development, controlled document management and process improvement

• Proven track record of building and leading high‑performing teams; experience developing talent into future leaders

• Direct experience with controlled document development within Clinical Development

• Strong knowledge of document management systems and digital workflow tools

• Deep understanding of CROs, third‑party vendors, and collaborative operating models

• Solid knowledge of FDA and ICH GCP guidelines and their application to clinical trials

• Exceptional communication and influencing skills; able to engage internal and external stakeholders at all levels

• Proven ability to drive multiple high‑impact initiatives in a fast‑paced, results‑oriented environment

Under Washington State law, Moderna is required to provide a reasonable…