Haleon
InspectionReadinessandAuditManager
“Inspection Readiness and Audit Manager at Haleon. Skills: Inspection Readiness, Audit Management, Pharmacovigilance, Quality Assurance. Coordinate and support regulatory Pharmacovigilance inspections. Support License Partner PV audits”
What You'll Achieve.
Drive improvements in Consumer Safety; Drive quality and processes improvements
Industry & Context.
Working towards resolution with complex problems
What They're Looking For.
Must Have
6 years of pharmaceutical industry experience in R&D and Quality/Compliance/ Pharmacovigilance/ other areas of vigilance/ Clinical Development/ GLP roles, Audit experience, Demonstrated hands-on experience in inspections conducted by Health Authorities and in inspection readiness, Specialization in Chemistry, Pharmacy, Biology or Life Science, Public Health or Healthcare Provider, Demonstrated ability to influence and negotiate with internal and external stakeholders, Knowledge of global, regional and national GVP GCP GLP regulatory requirements and guidelines, Detailed knowledge of pre and post marketing GVP GCP GLP activities associated with different areas of the business, Ability to deliver key process improvement initiatives, Ability to adapt to changing business and risk environment, Ability to work independently and make decisions with minimal supervision, High degree of organizational awareness and working towards resolution with complex problems, Demonstrated project management skills and management of complex cross-functional activities, Demonstrated good verbal, written and presentation skills
Nice to Have
Master of Science Degree or PhD Biology, Biochemistry, or equivalent
What You'll Do.
Coordinate and support regulatory Pharmacovigilance inspections
Support License Partner PV audits
Drive inspection readiness initiatives
Support GVP audit activities
Perform desktop audits
Author GxP QA written standards
Provide quality expertise review and approval
Generate/support delivery of PVQA and CDQA Management Monitoring
Provide quality metrics to identify trends
Serve as a Quality partner
Advise on compliance issues
Drive quality and processes improvements
Provide subject matter expertise on GVP compliance strategy
Train and coach R&D teams
Foster a quality culture
Provide subject matter expertise on GLP
GCP compliance strategy
Supports Haleon QPPV as required
How You'll Work.
Team & Collaboration
Coordinate with internal and external stakeholders; Serve as a Quality partner with Consumer Safety and Clinical Development stakeholders; Train and coach R&D teams
Communication Scope
Good verbal skills; Good written skills; Good presentation skills
Process & Methodology
Demonstrated project management skills, Management of complex cross-functional activities
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