Inspection Readiness Specialist

About the role

The Quality Inspection Readiness Specialist role supports the site before, during, and after regulatory inspections from Regulatory Agencies such as FDA. This includes coordination of internal and external audits and inspections, managing the internal audit program, and staying current with relevant regulations and industry trends.

Responsibilities

• Support the site Inspection Readiness program including coordination of internal and external audits and inspections.
• Manage and Support FDA and other regulatory inspections for the site; write and coordinate the issuance of a timely response to the Agency for any observations; and manage completion of commitments.
• Host Internal Corporate; write and coordinate the issuance of a timely response for any observations, including follow-up reports.
• Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
• Maintain Site Internal Audit and Self-Inspection programs.
• Communicate effectively and establish processes to ensure smooth communication within the department, across functions and across sites.
• Afford responsibility for other quality, product, and/or compliance activities as assigned.

Essential Qualifications and skills

• Demonstrate expert knowledge and ownership in key quality responsibilities below:
• Enhance the site inspection readiness program by: ensuring cross-functional inclusion of key SMEs are occurring to keep the site in ready inspection mode at all times; maintaining a frequently evaluated 'top issues' list of topics to be prepared to speak to during an inspection; ensuring frequent Gembas of the processes to understand the current state for any emerging top issues.
• Manage and Support FDA and other regulatory inspections for the site; write and coordinate the issuance of a timely response to the Agency for any observations; and manage completion of commitments.
• Host Internal Corporate; write and coordinate the issuance of a timely response for any observations, including follow-up reports.
• Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
• Maintain Site Internal Audit and Self-Inspection programs.
• Communicate effectively and establish processes to ensure smooth communication within the department, across functions and across sites.
• Afford responsibility for other quality, product, and/or compliance activities as assigned.

Salary Range

$110,178 to $151,494.20 plus a 12% Performance Bonus

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

2026-08-11

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to HR.AmericasSC-CS@haleon.com. Please include the following in your email: Use subject line: ‘Haleon Careers: Job Accommodation Request’ Your Name and contact information Requisition ID and Job Title you are interested in Location of Requisition (city/state or province/country) Description of specific accommodation you are requesting