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About the Role

The Quality Inspection Readiness Specialist supports the site before, during, and after regulatory inspections from agencies like the FDA, as well as internal and third-party audits, ensuring continuous audit readiness. This includes supplier and service provider auditing and managing the internal audit program.

Responsibilities

• Support the site Inspection Readiness program, coordinating internal and external audits and inspections.
• Manage the site audit plan, including issuing audit reports, communicating with managers, and tracking commitments.
• Prepare Inspection Readiness plans for regulatory agency inspections, corporate, and customer audits.
• Support regulatory inspections at the site.
• Manage the internal audit program.
• Stay current with relevant Federal, state, and corporate regulations, guidelines, policies, and industry trends.
• Support regulatory queries from different markets.
• Manage supplier and service provider required audits.
• Establish improvement processes and metrics across the department to add value to customers.
• Provide responsibility for other quality, product, and/or compliance activities as assigned.
• Enhance the site inspection readiness program by ensuring cross-functional inclusion of SMEs, maintaining a 'top issues' list, and conducting frequent Gemba walks.
• Manage and support FDA and other regulatory inspections, including responding to observations and managing commitments.
• Host internal corporate audits, respond to observations, and manage internal commitments.
• Maintain Site Internal Audit and Self-Inspection programs.
• Communicate effectively within the department, across functions, and between Site Leadership and the department.
• Approve GMP related documentation such as SOPs, CCs, Deviations, Validation/Qualification documents, and Technical Reports, including any associated changes.

Requirements

• Bachelor’s degree in science or relevant field and 5 years of experience in a regulated GMP industry.
• 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.
• Requires project management and leadership skills.
• Ability to work well under high pressure and deadlines.
• Must be flexible, adaptable, and a strong team player.
• Excellent verbal and written communication skills required.
• Conflict resolution and interaction management skills required.

Skills

• Quality Inspection Readiness
• Regulatory Inspections
• FDA Audits
• Internal Audits
• Third-Party Audits
• Supplier Auditing
• Service Provider Auditing
• Audit Program Management
• cGMP
• ICH Guidelines
• Project Management
• Leadership
• Analytical Problem-Solving
• Communication
• Conflict Resolution
• Interaction Management

Location

• Onsite

Work Type

• Full-time

Experience Level

• 5 years of experience in a regulated GMP industry

Education Level

• Bachelor’s degree in science or relevant field

Salary/Compensations

• $110,178 to $151,494.20

Benefits

• Competitive pay
• Generous 401(k) plan
• Tuition reimbursement
• Time off programs
• 6 months paid parental leave
• Healthcare programs with company paying majority of medical coverage
• Discretionary bonus based on key business performance
• Other incentive/recognition programs

About the Company

• Haleon is a purpose-driven, world-class consumer company focused on everyday health.
• Our trusted brands include Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum®.
• We combine deep human understanding with trusted science.
• Our Win as One strategy places our purpose – to deliver better everyday health with humanity – at the core of our operations.
• We foster an agile, performance-focused culture.

Equal Opportunity

• Haleon is committed to creating an inclusive culture where diverse backgrounds and views are valued and respected.
• We aim for Haleon to be a place where all employees feel they truly belong.
• Voluntary personal information may be collected to meet regulatory obligations and support inclusion and belonging programs.
• Personal information provided will be kept confidential and used only for legitimate business purposes, not for employment decisions.
• Haleon may be required to capture and report expenses for US Licensed Healthcare Professionals during the interview process to ensure compliance with US Transparency requirements.
• Reasonable accommodation requests can be made by emailing HR.AmericasSC-CS@haleon.com with specific details.