Associate Director, QA Operations, Drug Product

The Role

Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility.  This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP, corporate, regulatory and industry best practices.  The role is responsible for providing cross functional support for Commissioning, Qualification & Validation (CQV) activities which occur as part of the facility start up. 

The objective of this role includes the execution of an end-to-end project quality plan, which includes regulatory inspection readiness. The leader will liaise with key stakeholders to work through the facility integration strategy in addition to ensuring the appropriate quality systems and operational processes are developed, implemented, and maintained to ensure the seamless start-up and routine operation of the facility.  

Upon facility start-up this role will provide end-to-end quality oversight for drug product operations to ensure compliance with cGMPs, company procedures, and regulatory requirements.

The Associate Director will play a crucial role in establishing the operational strategy, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here’s What You’ll Do

In this role, your responsibilities will include:

• Establish robust operational readiness plans to transition from the construction phase to full-scale production, ensuring all systems and processes are in place for cGMP compliance,

• Develop, lead, and manage the execution of a project quality plan. Ensure the plan embeds an audit readiness component which factors all potential risks/mitigations associated with the project (i.e. facility, processes, personnel etc.) to ensure a successful pre-approval inspection.

• Oversee the hiring, training, and development of a high-performing Quality Operations team capable of providing Quality oversight across multiple Drug Product filling lines,

• Develop and implement operational and quality systems (i.e. deviation / change management, batch record management, cleaning & disinfection, personnel training, etc.) ensuring Quality 4.0 / Pharma 4.0 principles are embedded into their design.

• Collaborate with cross-functional teams working in a highly matrixed environment to drive decisions and influence outcomes to enable Moderna’s clinical pipeline,

• Ensure a detailed lesson learned is executed, documented, and disseminated to respective personnel upon project closure.

• Develop and track performance of quality and operational process readiness against pre-defined milestones – report on progress, risks, escalation, and resolution of issues through governance channels, where needed.

• Provide expert guidance and support while managing interfaces with key business stakeholders for quality and operational processes.

• Provide leadership to ensure a ‘Right-First-Time’ and mature quality culture is developed and maintained within the project leading to a successful PAI outcome.

• Support/lead troubleshooting of complex issues encountered during CQV activities. In addition, provide support for CQV deviations and change management teams.

• Represent quality in cross-functional project meetings; recruit, develop and lead personnel to ensure department and project objectives are met (i.e. quality, safety, cost).

• Ensure timely resolution and/or escalation of quality issues to senior management.

• In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System.

• In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve processes.

• Lead risk management activities to identify potential operational issues and implement mitigation strategies,

• Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the operations team,

• Establish key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize