Head of Global Contamination Control Governance

Position Summary

The Head of Enterprise Contamination Control Governance serves as the company's

global technical authority for contamination control and sterility assurance.

This role is responsible for establishing, implementing, and continuously

improving the enterprise contamination control framework, governance model, and

cross-site oversight program to ensure sustained compliance, inspection

readiness, and robust microbial control throughout the product lifecycle.

The position will lead the Contamination Control Governance Team (CCGT) and

transform contamination control from a site-driven specialist program into a

globally integrated operating system, culture, and management framework. The

role provides independent oversight and challenge of contamination risks,

investigations, root cause analyses, risk assessments, contamination control

strategies (CCS), and CAPA effectiveness across all sites.

Principal Duties and Responsibilities

1.Enterprise Contamination Control Strategy and Governance

Establish and maintain the global Contamination Control Strategy (CCS) governance framework across the organization.

Develop enterprise standards, policies, procedures, and governance requirements for contamination control.

Ensure alignment with:

EU GMP Annex 1

FDA Sterile Drug Guidance

PIC/S requirements

PDA technical reports

ICH Q9 and ICH Q10 principles

Lead annual CCS effectiveness and maturity assessments across all sites.

Establish a common contamination-risk language and global governance rhythm across the network.

2.Technical Authority for Contamination Risks

Serve as the company's highest-level technical authority and escalation point for:

Sterility assurance

Aseptic processing

Environmental monitoring

Cleanroom contamination control

Microbial contamination events

Water system contamination

Clean utility excursions

Mold investigations

Product contamination investigations

Facility contamination control risks.

Provide independent review and challenge of:

Risk assessments

Rootcause investigations

Significant contamination events

Sterility-related deviations

CAPA plans

CAPA effectiveness evaluations

Provide approval recommendations for high-risk contamination-related quality decisions.

3.Aseptic Assurance Program Leadership

Establish and oversee enterprise aseptic assurance programs including:

Aseptic Process Simulation (APS / Media Fill)

Aseptic Validation Strategy (AVS)

Critical intervention qualification

Personnel qualification and requalification

Gowning qualification programs

Operator aseptic behavior assessments

Contamination risk assessments for aseptic processing.

Drive harmonization of aseptic practices and interpretation of contamination risks across all manufacturing sites.

4.Clean Utilities and Facility Microbiological Oversight

Provide global oversight of:

Clean Utility Systems

Purified Water (PW)

Water for Injection (WFI)

Pure Steam Clean

Compressed Gases

Process Clean Utilities

Responsibilities include:

System design review

Microbiological control strategy

Trending methodologies

Alert and action level governance

Excursion investigation oversight

Lifecycle risk management

Facility and Cleanroom Design

Review and challenge:

Facility design concepts

HVAC design and qualification strategies

Pressure cascade design

Airflow visualization studies

Unidirectional airflow design

Barrier technologies

Restricted Access Barrier Systems (RABS)

Isolator technologies

Contamination control design qualifications

5.Airflow Visualization Studies (AVS)

Act as enterprise SME and governance leader for:

Airflow Visualization Studies (AVS)

Smoke studies

Dynamic smoke studies

Airflow qualification strategies

Ensure AVS programs:

Meet regulatory expectations

Support contamination control objectives

Demonstrate adequate protection of critical zones

Maintain harmonized interpretation standards globally

6.VHP and Sterilization Control Programs

Provide technical oversight for:

VHP Programs

VHP Cycle Development (CD)

VHP Cycle Validation (CV)

Bio-decontamination strategies

Biological indicator programs

Decontamination effectiveness verification

VHP requalification programs

Sterilization Programs

Moist Heat Sterilization

Dry Heat Sterilization

VHP Sterilization Filtration Sterilization

SIP Programs

DepyrogenationPrograms

Ensure robust lifecycle management and compliance of sterilization processes across all facilities.

7.Environmental Monitoring and In-Process Control Governance

Lead enterprise governance for:

Environmental Monitoring Programs

Personnel Monitoring Programs

Viable Monitoring

Non-Viable Monitoring

Trending Methodologies

Contamination Signal Detection

In-Process Microbiological Controls

Establish enterprise standards for:

Escalation thresholds

Significant event classification

Cross-site trending

Emerging contamination signal detection

Support implementation of proactive surveillance mechanisms.

8.Inspection Readiness and Regulatory Support

Serve as the contamination control technical lead during:

FDA inspections

EMA inspections

MHRAinspections

PMDA inspections

NMPA inspections

Client audits

Provide technical support and coaching during inspections involving:

CCS Sterility assurance

Aseptin operations

APS

AVS

EM programs

Water systems

Clean utilities

Contamination investigations

Support enterprise contamination risk reporting and inspection readiness activities.

9. Investigation

Excellence and CAPA Effectiveness

Develop and maintain enterprise standards for:

Contamination investigations

Microbiological root cause analysis

Sterility risk assessment

Mold investigations

Water excursion investigations

Trend investigations

CAPA effectiveness verification

Lead independent reviews of major contamination and sterility-related investigations across the network.

10.Capability Building and Culture Transformation

Establish the Enterprise Contamination Control Academy.

Develop global curricula for:

Aseptic processing

CCS

EM programs

APS

VS

Sterility assurance

Investigation excellence

Contamination risk management

Drive deployment of contamination-control lessons learned across all sites.

Lead enterprise initiatives to embed contamination control as an organizational culture and daily operating behavior rather than a specialist-owned activity.

Job Requirements

Education

PhD,MS, or equivalent degree in: Microbiology Pharmaceutical Sciences, Biological Sciences,Biotechnology,Sterility Assurance,Chemical Engineering,Related scientific discipline

Experience

Minimum 15-20 years of pharmaceutical or biotechnology industry experience.

Minimum 10 years in sterility assurance, microbiology, contamination control, or aseptic manufacturing.

Extensive experience supporting commercial sterile manufacturing operations.

Significant experience supporting FDA, EMA, and other major regulatory inspections.

Demonstrated experience leading global contamination control programs.

Highly Preferred

Former FDA Microbiology Reviewer

Former FDA Investigator with sterile manufacturing expertise

Former MHRA Sterile Inspector

Former EMA GMP Inspector

PDA or ISPE sterility assurance expert

Industry-recognized contamination control SME

Technical Competencies

Deep expertise in:

Microbiology

Environmental monitoring

Water microbiology

Mold management

Microbial identification

Recovery studies

Contamination pathways

Sterility Assurance

Additional Requirements:

Willingness to travel as needed to meet global operational requirements.

Fluency in English, with additional languages beneficial depending on the organization's geographic scope.

The preceding statements are intended to describe the general nature and level of

work being performed by people assigned to this role. They are not intended to

be an exhaustive list of all responsibilities, duties, and skills required of

personnel so classified.