Drive quality leadership and provide technical expertise on compliance strategy. * Communicate compliance status and issues to appropriate organizational levels. * Manage and follow-up of Deviations, OOS, Failure Investigations, Change Control, Qualification/Validation, Compliance Audit activities, Stability program, Lab Critical Materials, and documentation approval related to the PSQC Processes & Operations. * Implement and maintain adequate Quality & Compliance indicators and communicate results to appropriate levels of the organization * Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP. * Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by ...
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