Senior Manager, Process Compliance Review and Analysis… - Jobeax
Vacancy description
Senior Manager, Process Compliance Review and Analysis in Pune, भारत
Fortrea
Pune, भारत
Fortrea seeks a Senior Manager to establish and oversee quality processes for pharmacovigilance and safety writing engagements. The role involves driving compliance, process improvement, and audit readiness across assigned projects while serving as the quality expert for clients and delivery teams.
Responsibilities
Establish and implement quality processes across pharmacovigilance and safety writing engagements
Oversee quality reviews, metrics, analysis, and corrective actions across assigned projects
Drive CAPA management and audit readiness; identify quality trends and recommend improvements
Support internal and regulatory audits; ensure inspection readiness and client compliance during inspections
Develop SOPs, quality management plans, and provide inputs on training needs and process standardization
Requirements
Bachelor's, Master's, or PhD in Medicine, Medical Science, Pharmaceutical Science, Nursing, or Life Sciences
15+ years in pharmaceutical, biotechnology, or CRO industry focused on pharmacovigilance and safety writing
Knowledge of GPV regulations and applicable EU and FDA guidelines
In-depth understanding of single case processing, assessment, and safety writing
Familiarity with Lean and Six Sigma methodologies
Proficiency with Microsoft Office applications and system validations
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