Director, Commissioning, Qualification & Validation (CQV)

The Role:

Reporting to the Senior Vice President Facilities and Engineering, the Sr. Director for Global CQV will lead the Commissioning, Qualification and Validation Program for Global Capital Projects and CQV Program implementations at Moderna Global Facilities.  The candidate will lead a team of CQV FTEs and/or contractors supporting Capital Projects and CQV Global Program and Disciplines throughout the Moderna global footprint for Commercial Drug Substance and Drug Product operations.  Additionally, the candidate will also play an active role in providing guidance to cross-functional teams to establish and maintain a Global CQV Program, including Equipment CQV, Shipping Validation and Cleaning Validation for GMP and GLP assets, as well as Engineering lifecycle deliverables, continuous improvements initiatives and drive quality standards and compliance.

Travel to support CQV activities could be up to 20% at critical project phases.

Here’s What You’ll Do:

• Lead/Build/Develop and implement executable CQV Global strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices.

• Manage a cross-functional team of FTEs and/or contractors in alignment with Moderna values and culture.

• Lead CQV master schedules and planning activities for capital projects and programs within the global Moderna – determining scope, risk-based approach, and timelines considerations while working with cross-functional teams.

• Provide subject matter expert input and direction/guidance to all CQV lifecycle deliverables (i.e., user requirements, design specifications, process parameters, FMEA assessments, System risk assessments, Qualification and Validation protocols, etc…).

• Provide technical leadership and guidance on CQV activities, including equipment qualification, process validation, cleaning validation, shipping validation and computer system validation.

• Translate the business needs of the company into engineering solutions and develop CQV strategies.

• Negotiate and Influence in support of the Facilities and Engineering Organization with cross-functional stakeholders at Senior Leadership Level.

• Lead and support inspection readiness and health regulatory audits for CQV scope.

• Benchmark internally and externally to investigate and recommend such strategies.

• Drive results by owning and completing CQV capital projects and meeting the project timelines to ensure the schedule is not impacted. 

• The candidate must be able to drive results on multiple complex assignments simultaneously, in addition to reviewing and guiding the work and performance of FTEs and contractors.       

• Provide strategic direction and leadership for the CQV Global Org, aligning it with the overall business objectives of the F&E organization.

• Foster a culture of good engineering practices, quality excellence and continuous improvement within the F&E team and across the organization.

• Oversee the development and execution of qualification & validation master plans, risk assessments, and validation strategies for manufacturing processes and equipment.

• Support CQV quality records and ensure appropriate corrective and preventive actions are identified and implemented.

• Oversee the validation activities related to DS and DP manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements and quality standards.

• Partner with the Global Digital CSV team to create and maintain an integrated CQV and CSV approach for DS and DP manufacturing automated and process control integrated equipment/systems.

• Drive continuous improvement initiatives, identifying opportunities for efficiency and effectiveness in CQV processes.

• Ensure staff are adequately trained and competent in CQV activities, fostering a culture of quality and compliance.

• Stay updated with industry trends, regulatory changes, and best practices in CQV, ensuring the organization's practices remain compliant and competitive

• Collaborate with F&E and Digital to leverage AI and machine learning to support predictive maintenance, anomaly detection, and risk assessment.

• Other responsibilities per Capital Project requirements and needs.

Here’s What You’ll Bring to the Table:

• B.S. in Engineering.  B.S. degrees in other scientific or health-related fields will be considered.

• Minimum of 18 years in commissioning / qualification / validation experience in cGMP manufacturing environments.

• Proven experience leading Teams prior supervisory experience required.

• Strong understanding of valid