Overview
You will lead quality assurance efforts to uphold the QMS, ensure GMP/GDP compliance, and support batch release in a global pharmaceutical setting. In this role you will collaborate with internal teams, affiliates, and contract partners to drive continuous improvement and regulatory readiness. You’ll oversee deviations, investigations, CAPAs, change controls, and audits, shaping a culture of quality across manufacturing, packaging, and distribution. This position offers impact through strengthening compliance and operational excellence.
Responsibilities
- Maintain and enhance the Quality Management System (QMS) and ensure adherence to GMP, GDP, and regulatory requirements across manufacturing, packaging, testing, storage, and distribution
- Support batch review, release, and distribution activities to ensure timely supply of products
- Lead and support QA activities such as deviations, investigations, CAPAs, change controls, complaints, validation documents, PQRs, audit readiness, and inspection support
- Champion a culture of quality, compliance, and continuous improvement across the site and wider Quality Operations
Key requirements
- Experience in a Quality Management or Quality Assurance leadership role within the pharmaceutical industry
- Extensive knowledge of QA systems, GMP, GDP, and pharmaceutical manufacturing and packaging operations
- Strong Microsoft Office skills and proven communication, leadership, and stakeholder management abilities
- leadership
- communication
- stakeholder management
- QA systems
- GMP and GDP knowledge
- deviations, investigations, CAPAs
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