Associate Director, Commissioning, Qualification & Validation (CQV)

The Role

Reporting to the Associate Director of Global CQV, the Associate Director for CQV will support the Commissioning, Qualification and Validation efforts for the Commercial Individualized Neoantigen therapy “INT” Facility at Marlborough, MA.  The candidate will manage a team of CQV FTEs and/or contractors supporting the Capital Project Delivery Model. The candidate will establish and maintain the Global CQV Program as well as Engineering lifecycle deliverables, continuous improvements initiatives and drive quality standards and compliance at the Commercial INT Site ensuring a robust validation package and regulatory compliance and audit readiness at all times.

Travel to support CQV activities could be up to 15% at critical project phases, specifically Factory Acceptance tests executions.

Here’s What You’ll Do

• Develop and support the implementation of CQV Global strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices at the commercial INT 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 commercial INT capital project and programs – 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 DS and DP manufacturing 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 Capital Project requirements and needs.

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

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

• Minimum of 10 years in commissioning / qualification / validation experience in cGMP manufacturing environments.

• Proven experience leading Teams prior supervisory experience required.

• Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).

• Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.

• Must be able use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.

• Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers. Technical writing skills required.

• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.

• Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.

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