Inspection Readiness Specialist

Location: New York

## Inspection Readiness Specialist Apply locations:
USA
- New York
- Oak Hilltime type:
Full time posted on:
Posted Yesterday time left to apply:
End Date:
August 11, 2026 (19 days left to apply) job requisition :
543316

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

The purpose of the Quality Inspection Readiness Specialist role is to support the site before, during, and after regulatory inspections from Regulatory Agencies such as FDA. Internal Corporate and Third-Party audits and to ensure audit readiness at all times.  This includes supplier and service provider auditing as well as the oversight and maintenance of the internal audit program at the site.
* Support the site Inspection Readiness program including coordination of internal and external audits and inspections.
* Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting.
* Prepare Inspection Readiness plans for regulatory agency inspections, corporate and customer audits.
* Responsible for supporting inspections at the site
* Manages the internal audit program
* Stays current with all relevant Federal, state, and corporate regulations, guidelines, and policies and industry trends.
* Supports regulatory queries from different markets.
* Manages the Supplier and Service Provider required audits
* Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
* Provide responsibility for other quality, product, and/or compliance activities as assigned.
*
* Key responsibilities:

** 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. Ensure two-way communications between Site Leadership and the department.
* Approve GMP related documentation such as SOPs, CCs, Deviation, Validation/Qualification documents and Technical Reports. Approves any changes associated with these documents.
** Qualifications and skills
**** Essential
* * There is a range of educational experience allowed based on pharmaceutical experience obtained:
* Bachelor’s degree in science or relevant field and 5 years of experience in a regulated GMP industry
** Preferred
* ** Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines…