Hiring: Associate Director, Sterility Assurance Company: BioSpace Location: Norwood, MA Job Posted Time: 2026-09-02 18:07:01 Target Skills & Keywords : Chai About the job Required Skills: •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!