Moderna
Associate Director, Sterility Assurance
Norwood, Massachusetts, USA · Director · Contract
No sponsorship$143k-$257kDetected 28 days ago
Supply ChainGMPFDA RegulatoryLeadershipCollaborationGxP
About the role
- 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.
- Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections.
Responsibilities
- 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 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.
- 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.
- Coach operations and support personnel and partner with QA leadership to reinforce expectations and strengthen sterile execution culture.
- Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively manage sterility assurance risks across site activities.
Requirements
- Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
Nice to have
- Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred)
Compensation
- The salary range for this role is $142,500.00 - $256,500.00.
Benefits
- 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
- Location-specific perks and extras
Company info
- Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Visa & Work Authorization
- thout regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexua
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This listing is sourced directly from Moderna's careers page and normalized into a canonical job model.