Job Description

Our client within the Pharmaceutical Industry is looking for a QMS Manager / QP managing a team and reporting to the Head of QA.Responsibilities

• Oversee and manage the Quality Management System in line with EU GMP, GDP, and the Medicines Act in Malta.
• Ensure full regulatory compliance with Directive 2001/83/EC, S.L. 458, and EU GDP guidelines.
• Maintain readiness for all company's licences and coordinate with the Malta Medicines Authority.
• Lead day-to-day QMS operations, audits, SOPs, PQRs, CAPAs, and change control processes.
• Monitor and report QMS KPIs; propose and implement continuous improvement initiatives.
• Manage Technical Agreements, supplier qualifications, and regulatory inspections.
• Coordinate and deliver GMP/GDP/Quality training and maintain all related documentation.
• Oversee product recalls, returns, and serialisation processes in collaboration with QA and EU QA/RA/PV leadership.
• Represent the company during MMA and client audits and ensure compliance with national and EU standards.

Requirements

• Degree in Pharmacy, Chemistry, Pharmaceutical Science, Biology, or a related field; M.Sc./Ph.D. preferred.
• Extensive experience in Pharma QA/QC with a strong background in GMP and QP responsibilities.
• Solid knowledge of EU GMP, PIC/S, EMA guidelines, and quality systems (CAPA, audits, risk management).
• Proven experience in QMS implementation, auditing, and supplier quality management.
• Excellent leadership, communication, and coordination skills across cross-functional teams.
• High attention to detail with strong analytical and reporting abilities.
• Eligible and authorised as a Qualified Person (QP) under relevant EU and local regulations.

Benefits

• Health Insurance

Job Reference: KE590CategoryQuality AssuranceJob typeFull TimeEmployment levelMiddle ManagementWork LocationHybridEmployer industryPharmaceuticalsLanguagesEnglish, Maltese

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