Sterility Assurance Lead – Contamination Control

Dexian; Berkeley (CA); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Dexian seeks a Sterility Assurance Principal Specialist to lead the Sterility Assurance and Contamination Control program with senior-level accountability. You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and Quality Risk Management to translate strategies into actionable plans and governance materials.

You will drive metrics, action tracking, risk documentation, and inspection-readiness efforts, delivering clear documentation and

Qualifications

• Bachelor's degree in a science/engineering field.
• 8+ years in pharma/biotech sterile environments.
• Experience supporting contamination control, sterility assurance, quality systems, validation, QC Microbiology, or GMP program execution.
• Strong understanding of GMP quality systems, deviations, CAPA, change control, risk management, documentation, and inspection readiness.
• Demonstrated experience supporting cross-functional programs, action trackers, dashboards, risk registers, and leadership updates.
• Experience working with stakeholders across Quality, QC, Manufacturing, Engineering, Validation, Facilities, MSAT, or Technical Operations.

Responsibilities

• Support implementation of the Sterility Assurance and Contamination Control Program, including roadmap, workstream tracking, governance materials, and execution follow-up.
• Maintain CCS and sterility assurance action trackers with owners, due dates, dependencies, risk ranking, progress updates, and escalations.
• Prepare Sterility Assurance Council materials, including agendas, action logs, decision records, risk summaries, and leadership updates.
• Collaborate with Quality Risk Management to document, prioritize, escalate, and review contamination control risks.
• Develop site-level sterility assurance metrics by integrating QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations data.
• Produce periodic health summaries highlighting risk signals, gaps, overdue actions, contamination patterns, CAPA effectiveness, and readiness status.
• Assist with inspection-readiness activities related to CCS, governance, risk management, CAPA tracking, and program maturity.
• Develop and revise program tools such as charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communications.

Skills

Cross-functional coordination

GMP documentation discipline

Risk-based thinking

Inspection-readiness mindset

Technical writing

Program governance

Stakeholder management

Education

Bachelor's degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences, or related field

Tools

FMEA

HACCP

Risk registers

Job description

Dexian seeks a Sterility Assurance Principal Specialist to lead the Sterility Assurance and Contamination Control program with senior-level accountability. You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and Quality Risk Management to translate strategies into actionable plans and governance materials.

You will drive metrics, action tracking, risk documentation, and inspection-readiness efforts, delivering clear documentation and