Head of Enterprise Contamination Control 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

What if you could define the contamination control strategy for a global biologics network and influence how sterility assurance is managed across every site, every process, and every product?

A leading global biologics CDMO is seeking an exceptional contamination control and sterility assurance leader to establish, mature, and lead its Enterprise Contamination Control Governance function.

This is a newly created global leadership opportunity for an individual who combines deep technical expertise with the ability to build teams, influence senior stakeholders, and transform contamination control from a specialist discipline into an enterprise-wide culture of quality, risk management, and operational excellence.

For professionals passionate about sterility assurance, contamination control strategy, regulatory compliance, and technical leadership, this represents a unique opportunity to leave a lasting impact on a growing global biologics organisation.

The Opportunity

As Head of Enterprise Contamination Control Governance, you will serve as the organisation's highest-level technical authority for contamination control and sterility assurance.

You will be responsible for building and leading a global contamination control governance capability, developing the frameworks, standards, oversight mechanisms, and organisational capabilities required to drive consistency and excellence across an international manufacturing network.

Partnering closely with Quality, Manufacturing, Engineering, Validation, Microbiology, MSAT, and Executive Leadership teams, you will help shape the future state of contamination control whilst ensuring sustained inspection readiness and regulatory compliance.

This role offers significant executive visibility and the opportunity to influence quality strategy across multiple sites, regions, and functions.

What You'll Lead

Enterprise Contamination Control Strategy

• 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.

Technical Leadership & Oversight

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

You will provide independent challenge, oversight, and technical leadership on critical contamination-related decisions, investigations, and remediation activities.

Aseptic Manufacturing Excellence

• Oversee enterprise aseptic assurance programmes.
• 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 the interpretation and management of contamination risks.

Facilities, Utilities & Engineering Partnership

• 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.

Investigation Excellence & Risk Management

• 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.

Inspection Readiness & Regulatory Support

• 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 subject matter experts on regulator engagement and technical defence strategies.

Capability Building & Culture

• 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.

What We're Looking For

• Advanced scientific degree preferred (PhD, MS, PharmD or equivalent) in Microbiology, Pharmaceutical Sciences, Biotechnology, Biological Sciences, Engineering, Sterility Assurance, or a 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.
• Strong understanding of commercial sterile manufacturing operations.
• Proven experience supporting major global regulatory inspections.
• Demonstrated success leading contamination control or sterility assurance programmes across multiple sites or regions.

Highly Desirable Experience

• Former FDA Investigator with sterile manufacturing expertise.
• Former FDA Reviewer, MHRA Inspector, EMA Inspector, or equivalent regulatory authority experience.
• Recognised industry subject matter expert within contamination control or sterility assurance.
• Active involvement with PDA, ISPE, or equivalent industry bodies.
• Experience building, transforming, or harmonising global contamination control programmes.

Technical Expertise In

• Sterility Assurance
• Aseptic Processing
• Water Microbiology
• Clean Utilities
• HVAC & Cleanroom Design
• Airflow Visualisation Studies (AVS)
• VHP Validation
• Microbiological Investigations
• Compliance Risk Management

Additional Advantages

• Experience working across diverse international manufacturing networks.
• Ability to influence senior stakeholders and drive organisational change.
• Language skills considered advantageous but not essential.

The Ideal Leader

We are particularly interested in individuals who have moved beyond site-level contamination control and have successfully built enterprise-wide programmes, governance systems, and technical capabilities.

This role requires someone who can balance scientific rigour with executive influence, challenge established thinking, develop future leaders, and elevate contamination control to a strategic organisational capability.

You will be equally comfortable discussing sterility assurance strategy with executive leadership as you are reviewing a contamination investigation, coaching site specialists, or supporting a critical regulatory inspection.

Why Consider This Opportunity?

Newly created global leadership role

Opportunity to build and shape an enterprise contamination control function

Significant executive visibility and strategic influence

Partner with senior leaders across Quality, Operations, Engineering, and Manufacturing

Drive global sterility assurance and contamination control strategy

Build teams, capabilities, governance frameworks, and organisational culture

Play a critical role in supporting the manufacture of life-changing biologic therapies for patients worldwide

For a confidential discussion regarding this opportunity, please reach out directly.

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