Vice President of Quality

i‑Pharm Consulting; North Carolina; On-site; USD 260,000 - 340,000; Full time

Job summary

i-Pharm Consulting seeks a seasoned Quality & Compliance executive to establish and lead a Global Inspection Management function as VP/Head. The role blends regulatory mastery with program building, team development, and senior stakeholder influence to embed inspection readiness across a biologics manufacturing network.

You will define enterprise-wide strategy, govern systems, and drive readiness across sites and regions, partnering with global leaders to elevate standards, CAPA governance,

Qualifications

• 15+ years of experience in GMP Quality, Compliance, Regulatory Affairs, Inspection Management, or Health Authority oversight.
• Experience leading major regulatory inspections and remediation programmes.
• Experience across multiple sites, countries, or global regions.
• Proven ability to influence executive stakeholders and lead through complexity.

Responsibilities

• Design and implement a unified global inspection management framework across the enterprise.
• Establish governance structures, standards, policies, and inspection readiness programmes.
• Drive inspection excellence and consistency across international operations.
• Coach leaders and teams on inspection preparedness and regulatory engagement.

Skills

GMP Quality

Regulatory Affairs

Inspection Management

Quality Leadership

Stakeholder Influence

Education

Bachelor’s degree in Life Sciences or related field

MS/PhD/PharmD beneficial but not required

Tools

FDA inspection methodologies

Job description

What if you could build a global inspection readiness function from the ground up and influence quality strategy across an entire biologics manufacturing network?

A leading global biologics CDMO is seeking an experienced quality and compliance executive to establish and lead its Global Inspection Management function as their VP/ Head of Global Inspection Management.

This is a newly created leadership opportunity for an individual who combines deep regulatory expertise with the ability to build programmes, develop teams, influence senior stakeholders, and create a culture where inspection readiness is embedded into everyday operations.

For professionals who thrive at the intersection of strategy, compliance, leadership, and operational excellence, this presents a unique opportunity to make a lasting impact on a global organisation supporting the development and manufacture of critical therapies.

The Opportunity

As Head of Global Inspection Management, you will define and implement the organisation’s enterprise-wide inspection management strategy while establishing the governance, systems, and capabilities required to sustain long-term regulatory success.

Working closely with senior quality and business leaders, you will drive a proactive approach to inspection readiness, compliance risk management, remediation governance, and regulatory intelligence across an international manufacturing network.

This role offers significant visibility and influence, with responsibility for helping shape the future state of inspection readiness across multiple sites, functions, and regions.

What You’ll Lead

• Design and implement a unified global inspection management framework.
• Establish governance structures, standards, policies, and inspection readiness programmes.
• Drive inspection excellence and consistency across international operations.
• Build a sustainable model that moves organisations beyond periodic inspection preparation to continuous readiness.

Regulatory Inspection Leadership

• Lead strategic preparation for inspections from health authorities including FDA, EMA, MHRA, PMDA, NMPA, and other global regulators.
• Provide expert guidance during inspections and support executive decision-making.
• Partner with site leadership teams to strengthen regulator engagement and inspection performance.

Compliance & Risk Management

• Develop a global compliance risk management framework.
• Identify emerging regulatory risks and inspection trends.
• Lead governance of observations, CAPAs, remediation programmes, and effectiveness reviews.
• Translate inspection intelligence into meaningful, enterprise-wide improvement initiatives.

Capability & Team Development

• Build and develop a high-performing inspection management capability.
• Establish a network of inspection readiness champions across the organisation.
• Coach leaders and subject matter experts on inspection preparedness and regulatory engagement.
• Foster a culture of proactive compliance, accountability, and continuous improvement.

What We’re Looking For

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, Microbiology, Chemistry, or a related discipline.
• Advanced degree (MS, PhD, PharmD) beneficial but not essential.
• 15+ years of experience within GMP Quality, Compliance, Regulatory Affairs, Inspection Management, or Health Authority oversight.
• Significant experience within biologics, sterile manufacturing, vaccines, advanced therapies, or pharmaceutical manufacturing environments.
• Demonstrated success leading major regulatory inspections and remediation programmes.
• Experience operating across multiple sites, countries, or global regions.
• Proven ability to influence executive stakeholders and lead through complexity.

Highly Desirable Experience

• Former FDA Investigator, Compliance Officer, Compliance Reviewer, Team Leader, or equivalent regulatory authority experience.
• Experience building or transforming inspection readiness programmes, compliance functions, or quality capabilities.
• Strong understanding of FDA inspection methodologies, 483 management, warning letter remediation, Quality Systems, Data Integrity, and Risk Management.
• German, French or Mandarin language skills would be considered advantageous.

The Ideal Leader

We’re particularly interested in leaders who have not only managed inspections but have built sustainable systems, developed people, driven organisational change, and elevated quality culture at scale.

You will be equally comfortable presenting to executive leadership, engaging with regulators, challenging compliance risks, and developing the next generation of inspection readiness leaders.

Why Consider This Opportunity?

• Newly created global leadership position
• Opportunity to build and shape a critical quality capability
• High visibility across executive and operational leadership teams
• Influence regulatory strategy across a complex biologics manufacturing network
• Drive global standards, compliance excellence, and inspection readiness
• Play a key role in supporting the delivery of life-changing therapies to patients worldwide

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

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