Associate Director, Sterility Assurance

The Role

The Associate Director, Sterility Assurance, DP Manufacturing is a senior technical role dedicated to the MTC-E facility and accountable for the design, implementation, and oversight of the site's Contamination Control Strategy (CCS) program. This role ensures sterility assurance activities are aligned with regulatory expectations, operational requirements, and best practices in aseptic manufacturing.

This is a high-impact, hands-on role requiring frequent presence on the manufacturing floor to observe, assess, and improve aseptic behaviors, process execution, and contamination control practices. The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, Engineering, Supply Chain, and Quality to integrate sterility assurance into all layers of site operations. The individual must be technically strong, data-driven, and proactive in identifying risks and driving continuous improvement across the site.

Key Responsibilities and Authorities of the Position

• Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations.
• Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution.
• Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control.
• Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy.
• Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions.
• Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making.
• Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices.
• Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements.
• Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections.
• Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics.
• Lead or support drafting of inspection responses and implementation of remediation actions arising from audit or inspection findings.
• Support real-time issue resolution and verify execution of validated and approved aseptic practices.
• Conduct routine floor audits and observations to assess aseptic behaviors, gowning, EM practices, and adherence to contamination controls.
• Coach operations and support personnel and partner with QA leadership to reinforce expectations and strengthen sterile execution culture.
• Support the site aseptic training, qualification, and certification programs.
• Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively manage sterility assurance risks across site activities.
• Identify and assign appropriate deputies to support business in times of absence.
• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Required Background:

• Education: Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred)
• Experience: 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
• Other Quantifiable Preference: Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations. Strong expertise in risk assessment facilitation. Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership.
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

Pay & Benefits

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