Inspection Readiness Lead – Regulatory & Audit Programs

Haleon; Northern, New York (KY, NY); Hybrid; USD 110,000 - 151,000; Full time

Benefits offered by this job

Performance bonus

Job summary

Haleon seeks an Inspection Readiness Specialist for our New York Oak Hill site. You will support FDA and other regulatory inspections, coordinate internal and external audits, and maintain the site audit program to ensure readiness at all times.

Responsibilities include preparing inspection readiness plans, issuing timely responses to observations, managing audit reports, and tracking commitments while staying current with GMP and regulatory requirements.

Qualifications

• Bachelor’s degree in science or relevant field and 5 years of experience in a regulated GMP industry.
• Knowledge of cGMPs/FDA and ICH guidelines is preferred.
• Strong analytical and problem-solving skills with data-driven decision making.

Responsibilities

• Coordinate internal and external audits and inspections for the site.
• Manage the site audit program, including issuing reports and tracking commitments.
• Prepare inspection readiness plans and responses to regulatory observations.
• Maintain site internal audit and self-inspection programs and ensure timely communications.

Skills

Project management

Leadership

Analytical problem-solving

GMP knowledge

Regulatory compliance

Education

Bachelor's degree in science or relevant field

Job description

Haleon seeks an Inspection Readiness Specialist for our New York Oak Hill site. You will support FDA and other regulatory inspections, coordinate internal and external audits, and maintain the site audit program to ensure readiness at all times.

Responsibilities include preparing inspection readiness plans, issuing timely responses to observations, managing audit reports, and tracking commitments while staying current with GMP and regulatory requirements.