QA Sr. Manager, Drug Product

The Role

Reporting to the Associate Director, QA Drug Product, the QA Sr. Manager, Drug Product Operations is responsible for coordinating and executing 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 will be required to provide quality oversight of Commissioning, Qualification & Validation (CQV) activities which occur as part of the facility start up, in addition to the support and execution of an end-to-end project quality plan, which includes regulatory inspection readiness.

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 QA Manager will play a crucial role in executing the operational strategy 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:

• Executing 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,

• Execution of a project quality plan, paying key attention to the audit readiness components to ensure a successful pre-approval inspection.

• Assist with the development and implementation of 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

• Routinely identify and escalate project quality risks, and proposed resolution through governance channels, where needed.

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

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

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

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

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

• Support the development of key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize processes,

• Foster a culture of innovation and collaboration, encouraging team members to contribute ideas for process improvements and operational excellence,

• Drive and/or support continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality,

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

• Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology discipline.

• A minimum of 8 years of experience in aseptic drug product manufacturing.

• Problem-solving mindset with a commitment to quality and safety.

• In-depth knowledge of cGMP regulations, aseptic processing, and cleanroom operations.

• Strong leadership skills with the ability to develop and motivate a diverse team.

• Excellent project management, organizational, and communication skills.

• Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders, with the ability to convey complex information in an understandable manner to various stakeholders.

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

• Proven track record of successful facility start-ups or major operational projects (e.g. Greenfield or Brownfield Projects) within the pharmaceutical industry.

• A desire to make an impact as part of a high-