Regulatory Readiness Lead - Quality & Inspections

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

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.