Senior Director, Global Inspection Management

About the role

This role establishes and leads a global inspection management program to advance rare disease medicine development. The Senior Director ensures consistent regulatory compliance across internal and external operations, enabling innovative treatment delivery. Success in this role supports the organization's mission to deliver therapies while fostering a collaborative, inclusive culture. The position requires a leader who can translate complex regulatory landscapes into actionable strategies for the organization. You will own the end-to-end lifecycle of inspection readiness, turning potential risks into opportunities for operational excellence. This role demands ownership of both strategic vision and the detailed execution plans that make global compliance possible. You will be a key architect in aligning inspection practices with the company's commitment to rare disease innovation. Ultimately, this position drives confidence with regulators by ensuring the organization is predictably prepared.

Key facts

What you'll do

A global inspection management framework and governance are shaped to standardize practices worldwide. Timely and effective CAPA development and implementation address inspection findings and close regulatory observations. Inspection readiness assessments are conducted, and CMOs are supported during regulatory inspections to align practices. Inspection training programs are developed and delivered for SMEs and site leadership to build consistent capabilities. Cross-functional inspection readiness teams and governance forums are led to align priorities and share best practices. The company is represented in external forums and industry groups to advance inspection standards and regulatory dialogue. Complex inspection histories are analyzed to identify trends and implement sustainable systemic improvements. You will oversee the development and maintenance of global standard operating procedures for inspection readiness. Detailed risk assessments are performed to prioritize inspection activities and allocate resources effectively. Metrics and key performance indicators are established to measure the effectiveness of inspection management initiatives.

Requirements

A Bachelor's degree in Life Sciences or related field is required; an advanced degree is preferred. A proven track record of leading global regulatory inspections and readiness programs is necessary. Strong knowledge of global GMP regulations and inspection practices is mandatory for this role. Experience with both internal operations and external manufacturing oversight is required to ensure site consistency. Excellent communication, leadership, and project management skills are essential for cross-functional success. The ability to influence across levels and functions in a matrixed organization is required to drive alignment. Experience with biologics or gene therapy manufacturing is expected to manage complex programs. Prior experience working with global CMOs and managing complex supply chains is required for external oversight. Familiarity with digital tools for inspection management and quality systems is required to support efficient workflows. Up to 25% travel may be required (domestic and international) to support site activities.

Practical notes

Equal opportunity employer; reasonable accommodation is available for protected statuses. Typical interview steps

Leadership hiring usually includes a strategy case, a people scenario, and a values conversation. Candidates may be asked to turn around a struggling team or plan for growth. Past results are examined closely, especially how decisions were made. Interviewers dig into specific decisions you made and their consequences. Preparing two or three decision stories with numbers and lessons is the best use of time.

Career growth

Leadership careers move from manager to senior manager, director, and executive roles. Each step adds more scope and more responsibility for outcomes. The best leaders keep learning how to delegate, communicate, and decide. Leadership careers reward a record of building and developing people. The higher you go, the more your communication shapes the whole organization.