Global Head, Contamination Control & Sterility Governance

i‑Pharm Consulting; New Jersey; On-site; USD 200,000 - 260,000; Full time

Job summary

i-Pharm Consulting seeks a leader to define the contamination control strategy for a global biologics network and to mature the Enterprise Contamination Control Governance function across sites, regions, and functions.

You will lead the global governance framework for CCS, set standards, and drive regulatory alignment while partnering with Quality, Manufacturing, Engineering, and executive teams to ensure inspection readiness and continuous improvement.

Qualifications

• Advanced scientific degree preferred (PhD, MS, PharmD or equivalent) in Microbiology, Pharmaceutical Sciences, Biotechnology, Biological Sciences, Engineering, Sterility Assurance, or related discipline.
• 15+ years of experience within pharmaceutical, biotechnology, biologics, vaccine, or sterile manufacturing environments.
• Extensive experience in sterility assurance, microbiology, contamination control, or aseptic manufacturing leadership.

Responsibilities

• Develop and implement a global Contamination Control Strategy (CCS) governance framework.
• Establish enterprise-wide standards, policies, procedures, and best practices.
• Drive alignment with Annex 1, FDA expectations, ICH principles, and global regulatory requirements.
• Create a consistent contamination risk management approach across all sites and operations.
• Act as the organisation's senior technical authority for: sterility assurance, aseptic processing, cleanroom contamination control, water and utility systems, facility contamination risks, product contamination investigations.
• Oversee enterprise aseptic assurance programmes and drive standardisation of aseptic practices across the global network.
• Support media fill programmes, aseptic validation strategies, personnel qualification programmes, and contamination risk assessments.
• Ensure consistency in interpretation and management of contamination risks.
• Provide strategic oversight of contamination control within clean utilities and manufacturing infrastructure.
• Support governance surrounding WFI, purified water, pure steam, and clean utility systems.
• Partner with Engineering and Facilities teams regarding cleanroom design, HVAC strategies, airflow management, barrier technologies, RABS, isolators, and contamination control design principles.
• Establish global standards for contamination investigations and sterility-related root cause analysis.
• Oversee significant contamination events and remediation programmes.
• Challenge investigation quality, risk assessments, CAPA plans, and effectiveness reviews.
• Translate lessons learned into sustainable improvements across the global network.
• Serve as a key technical leader during global regulatory inspections and client audits.
• Support inspection readiness activities related to contamination control, sterility assurance, environmental monitoring, aseptic operations, utilities, and microbiological control systems.
• Coach leaders and SMEs on regulator engagement and technical defence strategies.
• Build and develop a high-performing contamination control governance capability.
• Establish global education and training programmes focused on contamination control and sterility assurance.
• Develop contamination control champions across the organisation.
• Embed contamination control as a daily operating culture rather than a specialist-owned activity.

Skills

Contamination control leadership

Sterility assurance

Executive stakeholder influence

Regulatory compliance

Team building

Education

Advanced scientific degree (PhD, MS, PharmD) or equivalent in related discipline

Job description

i-Pharm Consulting seeks a leader to define the contamination control strategy for a global biologics network and to mature the Enterprise Contamination Control Governance function across sites, regions, and functions.

You will lead the global governance framework for CCS, set standards, and drive regulatory alignment while partnering with Quality, Manufacturing, Engineering, and executive teams to ensure inspection readiness and continuous improvement.