Associate Director, Commissioning, Qualification & Validation (QVC)

The Role

Reporting to the Senior Director of Validation, the Associate Director for CQV will support the Commissioning, Qualification and Validation efforts for the clinical and commercial operations occurring at the MTC-S Facility at Norwood, MA.  The candidate will manage a team of CQV FTEs and/or contractors supporting both capital projects and day-to-day operations. The candidate will maintain MTC-S Facility’s CQV Program as well as Engineering lifecycle deliverables, continuous improvements initiatives and drive quality standards and compliance at the MTC-S Facility ensuring a robust validation package and regulatory compliance and audit readiness at all times.

Here’s What You’ll Do

• Develop and support the implementation of CQV site strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices at the MTC-S Facility.

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

• Support CQV master schedules and planning activities for MTC-S Facility projects, programs, and day-to-day operations – determining scope, risk-based approach, and timelines considerations while working with cross-functional teams.

• Provide 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…).

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

• Support in benchmarking internally and externally to investigate and recommend such strategies.

• Contribute to the successful completion of 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.

• Support the strategic direction 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.

• Support 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.

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

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

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

• Other responsibilities per projects, programs, and day-to-day operations requirements and needs.

• Additional duties as may be assigned from time to time

Here’s What You’ll Bring to the Table

• Bachelor's degree in engineering, facilities management, or a related field is preferred. Equivalent experience and certifications may be considered.

• Minimum of 10 years of experience in utility maintenance, with a significant portion of that experience in a fast-paced pharmaceutical environment, with a focus on reliability and performance management.

• In-depth knowledge of utility systems specific to the pharmaceutical industry, including HVAC, electrical, plumbing, and mechanical systems, with a strong understanding of GMP guidelines and regulatory requirements, and a proven track record in reliability and performance improvement in a fast-paced setting.

• Strong troubleshooting and problem-solving skills, with the ability to analyze complex issues and develop effective solutions while maintaining compliance with GMP guidelines and regulatory requirements, with a focus on reliability and performance enhancement in a fast-paced environment.

• Proficient in reading and interpreting technical manuals, blueprints, and schematics specific to pharmaceutical utility systems.

• Ability to work in a fast-paced, high-pressure environment.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comp