The Associate, Quality & Compliance will support the ITP Division Quality Compliance function by assisting with procedure management, quality system harmonization, and compliance initiatives across the global manufacturing network. The role will work with site and functional teams to help ensure quality processes remain standardized, compliant, and aligned with applicable regulatory requirements.
Quality Systems Support: Support the maintenance and continuous improvement of the ITP Division Quality Management System; Assist with implementation of standardized quality processes; Support quality system initiatives and compliance improvement activities.
Procedure Management: Draft, revise, review, and maintain global quality procedures and related documents; Coordinate periodic procedure reviews and updates; Ensure procedures remain aligned with current regulatory and corporate requirements.
Site Coordination: Partner with site quality teams to support adoption of standardized processes; Coordinate feedback and alignment activities; Support communication of quality system updates across the network.
Compliance Support: Assist in assessing procedures and processes against applicable global GMP and combination product requirements; Support monitoring of regulatory changes; Promote compliance and quality culture.
Metrics and Reporting: Support collection, analysis, and reporting of quality system metrics; Assist with management review; Identify and escalate quality system trends or gaps.
Audit and Inspection Readiness: Support internal and external audit readiness activities; Assist with responses and follow-up actions related to quality system observations.
Bachelor’s or Master’s degree in pharmacy (B. Pharm / M. Pharm) with 6 to 10 years of experience in pharmaceutical manufacturing quality, compliance, or quality systems.
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