**Digital Quality Assurance Leader Wanted**
We are looking for a highly skilled professional to take on the role of Digital Quality Assurance Leader. In this position, you will be responsible for ensuring the standards and reliability of digital systems supporting production, lab, and storage functions.
You will lead efforts in data governance, system validation, and inspection readiness while fostering a culture of continuous improvement and compliance.
Key Responsibilities:
* Implement quality standards for electronic systems and data management.
* Oversee the validation and compliance of computerized systems, including manufacturing and laboratory platforms.
* Conduct inspections and assessments to ensure adherence to regulatory requirements.
* Manage system change controls, deviations, and corrective actions.
* Develop frameworks to ensure data quality and integrity across all processes.
* Provide oversight for systems such as MES, DeltaV, LIMS, ELN, and SAP.
* Support automation initiatives and system integration projects.
* Prepare for and participate in regulatory inspections and audits.
* Train and mentor team members on data integrity and compliance practices.
Requirements:
* A background in science, engineering, computer science, or a related field.
* Knowledge of regulatory standards (e.g., FDA, EMA) and data integrity principles.
* Experience with laboratory systems (e.g., LIMS, CDS, ELN) and enterprise platforms (e.g., SAP, MES).
* Strong leadership, communication, and decision-making skills.
* Familiarity with system validation processes, including risk-based approaches.