Manager QA IT

Description

• Computer System Validation (CSV) & IT Oversight - lead and support validation activities for laboratory and manufacturing systems (LIMS, CDS, MES, EBR, QMS, etc.). Ensure systems comply with 21 CFR Part 11, Annex 11, and other applicable data integrity requirements. Review and approve user requirements, validation documentation, and change controls related to computerized systems.
• Quality & Compliance - ensure data integrity across all computerized systems in compliance with ALCOA+ principles. Develop and review protocols, and policies related to electronic systems and IT quality processes.
• Collaboration & Support - act as liaison between QA, IT, laboratory staff, and manufacturing operations. Train users on data integrity, electronic records, and compliance with IT-related systems. Support electronic quality management systems (QMS) for deviations, and change management.
• Risk & Security - conduct IT-related risk assessments for laboratory and manufacturing systems. Oversee access controls, audit trails, and cybersecurity considerations for regulated systems. Support disaster recovery planning and data backup/restore processes in alignment with compliance requirements.
• Change control, SOP/Guideline management, Risk Analysis, CSV lifecycle based on ISPE GAMP5 guidance, and Periodic Reviews
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or related field. Extensive years of experience in IT within a pharmaceutical, biotech, or medical device industry.
• Knowledge of FDA, EMA, and ICH regulations, including 21 CFR Part 11 and EU Annex 11.Experience with Computer System Validation (CSV).
• Understanding of laboratory and manufacturing computerized systems (LIMS, CDS, MES, EBR, TrackWise, Master Control, etc.).
• Ability to interpret regulatory requirements and apply them to IT and digital systems.
• Problem-solving, risk assessment, and documentation skills.
• Familiarity with GAMP 5 guidelines for computerized systems.
• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
• Ability to perform computations such as percentages, ratios, and rates.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.