Associate Director, Sterility Assurance Job at Moderna (Norwood)

Job Description

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.

Job Responsibility

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

Requirements

Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred)
8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
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

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Eligible for an annual discretionary bonus, other incentive compensation, or equity award

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Associate Director, Sterility Assurance

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