Job Overview
The Quality Assurance Lead plays a critical role in ensuring compliance, data integrity and operational excellence across regulated pharmaceutical operations.
This is a highly experienced position that involves leading quality and compliance aspects of an ERP transformation.
Key responsibilities include defining and implementing the QA strategy for ERP systems, establishing and enforcing quality governance frameworks, policies and procedures, and collaborating with consultants, business stakeholders and technical teams to embed quality requirements into system design and configuration.
The successful candidate will have in-depth knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments, as well as practical experience with quality management, batch management and inspection planning.
Main Responsibilities:
* Leading quality assurance initiatives to ensure GxP compliance, data integrity and operational excellence.
* Defining and implementing QA strategies for ERP systems.
* Establishing and enforcing quality governance frameworks, policies and procedures.
* Collaborating with consultants, business stakeholders and technical teams to embed quality requirements into system design and configuration.
* Maintaining quality KPIs and driving continuous improvement initiatives.
* Providing quality insights to manufacturing, supply chain and regulatory teams.
Requirements
* 5+ years of quality assurance experience in regulated pharmaceutical or CDMO environments.
* Extensive ERP implementation experience with a strong focus on SAP systems.
* Demonstrated leadership in CSV and QA-driven ERP projects.
* Familiarity with tools such as Signavio for process modelling and validation traceability.
* Experience with AI/ML tools for quality monitoring and validation (desirable).