Job Title: Associate Director - Computer System Quality Assurance & Site Data Lead
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Job Summary
We are seeking an experienced Associate Director to lead our computer system quality assurance and site data management initiatives. The ideal candidate will have a strong background in science, engineering, or computer science, with expertise in regulatory standards and data integrity principles.
Key Responsibilities
* Develop and implement quality standards for electronic systems and data management.
* Oversee 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
* Background in science, engineering, computer science, or a related field.
* Knowledge of regulatory standards (e.g., FDA, EMA, GAMP 5) 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.
Benefits
This is a fantastic opportunity to work with a leading pharmaceutical company, driving innovation and delivering impactful research that improves healthcare outcomes. As an Associate Director, you will have the chance to develop your skills, build your network, and make a real difference in the industry.