Inspection Readiness Specialist

Haleon; Oak Hill (WV); On-site; USD 110,000 - 151,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Parental leave

Job summary

Haleon is seeking a Quality Inspection Readiness Specialist to support the site before, during, and after regulatory inspections by agencies such as FDA. You will oversee internal and supplier audits, maintain the internal audit program, and ensure ongoing inspection readiness across the site and functions.

The role requires a Bachelor’s in science with 5 years in GMP settings, along with strong project management, leadership, and communication skills.

Qualifications

• Bachelor’s degree in science or relevant field and 5 years of experience in a regulated GMP industry.

Responsibilities

• 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.

Skills

Regulatory inspections

Audit readiness

GMP compliance

SOP approvals

Project management

Leadership

Communication

Problem solving

Education

Bachelor’s degree in science

Job description

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.

Key responsibilities:

• 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.

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

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 8, 9, 10, 11.
• Demonstrate initiative and analytical problem-solving skills – ability to use and interpret data to drive decision making at both tactical and strategic level.
• Requires project management and leadership skills.
• Ability to work well under high pressure and deadlines
• Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies.
• Excellent verbal and written communication skills required.
• Conflict resolution and interaction management skills required

The salary range for this position is $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

2026-09-28

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

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 [e-mail]. 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
• Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.