Head of Global Inspection Management

Position Summary:

The Head of Global Inspection Management is responsible for establishing and

leading the company's global inspection management framework to ensure

sustained inspection readiness across all sites, functions, and quality

systems. The role serves as the enterprise leader for regulatory inspection

strategy, compliance risk identification, inspection governance, and

organizational preparedness for health authority inspections.

This position will drive a proactive, risk-based approach to inspection readiness

and regulatory compliance by integrating lessons learned from inspections,

audits, quality events, and emerging regulatory expectations into a unified

enterprise-wide inspection management system.

The role will chair the Global Inspection Management Governance Committee and

partner with site leadership, Quality, Operations, Engineering, MSAT,

Regulatory Affairs, and global functions to ensure consistent execution of

inspection readiness programs across all manufacturing and development sites.

Principal Duties and Responsibilities

1. Establish Global Inspection Management

Framework Design and implement the Global Inspection Management Framework across all sites and

functions.

Develop inspection management policies, procedures, standards, and governance

structures.

Establish enterprise inspection readiness requirements, inspection playbooks, and

response protocols.

Create standardized processes for:

Inspection preparation

Inspection execution

Observation management

Regulatory response development

Remediation governance

Effectiveness verification

Drive harmonization of inspection management practices globally.

2.Enterprise Inspection Readiness Leadership

Develop and maintain a continuous inspection readiness program across all sites.

Ensure inspection readiness is embedded into routine business operations rather than periodic preparation activities.

Establish a sustainable inspection readiness operating model including:

Site readiness assessments

Mock inspections

Document readiness reviews

Data integrity readiness reviews

SME preparation and coaching

Inspection war-room management processes

Define and maintain inspection readiness KPIs and maturity metrics.

3.Compliance Risk Management

Develop an enterprise regulatory compliance risk management framework.

Establish methodologies to identify, assess, prioritize, and monitor compliance risks.

Maintain a Global Compliance Risk Register.

Lead periodic compliance health assessments across all sites.

Identify emerging regulatory trends and proactively assess potential impacts.

Ensure appropriate escalation and mitigation of significant compliance risks.

4.Inspection Governance

Establish and chair the Global Inspection Management Governance Committee.

Provide regular inspection readiness and compliance risk reports to Executive Management and the Board.

Drive accountability for inspection-related commitments and remediation actions.

Facilitate governance reviews of:

Inspection observations

Recurring inspection trends

Critical compliance risks

CAPA effectiveness

Enterprise compliance initiatives

5.Regulatory Inspection Strategy

Serve as the enterprise subject matter expert for regulatory inspection management.

Lead strategic planning for major inspections including:

FDA

EMA

MHRA

PMDA

NMPA

TGA

Health

Canada

Other global health authorities

Guide executive leadership and sites on inspection response strategies.

Provide strategic oversight during regulatory inspections.

Coach site leadership and subject matter experts on regulator engagement.

6.Inspection Observation Management

Lead global governance of regulatory observations, commitments, and remediation programs.

Ensure consistent root cause analysis methodologies across sites.

Review and challenge proposed CAPAs for adequacy and sustainability.

Monitor effectiveness of remediation programs through governance reviews.

Ensure lessons learned are systematically deployed across the network.

7.Inspection Intelligence and Regulatory Surveillance

Establish a global inspection intelligence program.

Monitor major industry warning letters, inspection trends, FDA 483 observations, and regulatory enforcement actions.

Translate regulatory intelligence into actionable improvement initiatives.

Maintain executive reporting on emerging regulatory risks and industry trends.

8.Global Network Oversight

Conduct periodic inspection readiness assessments at all sites.

Partner with site quality heads to ensure readiness programs remain effective.

Drive consistency in inspection performance across the network.

Support integration of newly acquired or newly commissioned sites into the inspection readiness framework.

9.Executive and Regulatory Engagement

Act as senior advisor to Executive Leadership Team on regulatory compliance and inspection readiness matters.

Support interactions with regulators, clients, and external auditors as required.

Represent the company at industry forums and regulatory engagement activities.

10.Leadership and Organization Development

Build and lead a high-performing Global Inspection Management organization.

Develop enterprise inspection management capabilities and training programs.

Establish a network of inspection readiness champions at each site.

Drive a culture of proactive compliance and regulatory excellence.

11. Member of Global Quality leadership team.

12. Representing the company to external parties with focus on GMP compliance.

13. Recruiting and management of Global inspection management Staff.

14. Preparing budget and management of expenditure in line with budget for quality functions and activities.

15. Approval, and where required preparation, of capital expenditure requests for siteimprovement and renovation projects

Job Requirements

1. Education

Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, Microbiology,

Chemistry, or related field.

Advanced degree (MS, PhD, PharmD) preferred.

2. Experience

Minimum 15-20 years of experience in GMP quality, compliance, regulatory inspection management, or health authority oversight.

Significant experience within biologics, sterile manufacturing, vaccines, cell & gene therapy, or pharmaceutical manufacturing environments.

Demonstrated leadership of major regulatory inspections.

Experience managing enterprise compliance programs across multiple global sites.

3. Highly Preferred

One or more of the following:

Former FDA Investigator

Former FDA Compliance Officer

Former FDA Compliance Reviewer

Former FDA Team Leader

4. TechnicalCompetencies

Deep expertise in:

FDA Inspection Programs

FDA 483 Management

Warning Letter Remediation

Quality System Inspection Technique (QSIT)

Pharmaceutical Quality Systems (ICH Q10)

Risk Management (ICH Q9)

Data Integrity Governance

Contamination Control Strategy (CCS)

Deviation and CAPA Systems

Management Review Systems

Compliance Risk Management

Inspection Readiness Programs

5. Leadership Competencies

Executive presence

Strategic thinking

Regulatory influence

Governance leadership

Enterprise risk management

Cross-functional leadership

Crisis management and decision making

Stakeholder engagement

Change leadership

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.