Manager, Global Quality Tech Ops-Digital Transformation & Innovation

PCI Pharma Services

PCI Pharma Services seeks a Manager of Global Quality Tech Ops to lead digital transformation initiatives, focusing on MasterControl system optimization, quality metrics automation, and regulatory compliance. The role bridges traditional quality workflows with modern digital platforms across a global pharmaceutical network.

Responsibilities

Lead global MasterControl technical enhancements and system integrations with ERP platforms
Design and maintain automated quality metrics dashboards tracking KPIs and compliance trends
Develop validation documentation and ensure adherence to GAMP 5 and FDA regulatory standards
Transform paper-based quality workflows into streamlined digital processes within MasterControl
Establish data integrity governance frameworks meeting FDA, EMA, and MHRA requirements

Requirements

Bachelor's degree in related field or 5-7 years equivalent experience
Advanced computer skills and proficiency with complex software systems
College-level mathematical ability and analytical thinking
Fluent professional communication in speaking, reading, and writing
Expertise in MasterControl configuration and system integrations
Strong data visualization and SQL knowledge preferred
Knowledge of GAMP 5, FDA 21 CFR Part 11, and Annex 11 regulations

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Vacancy posted 6 days ago

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