Computerized System QA Manager

Initial 3 Months Contract with possibility to extend till 6 Months

The Computerized System QA Manager is responsible for establishing and maintaining a robust quality framework for

Gx P computerized systems

, electronic records, electronic signatures, data governance and data integrity.

The role ensures systems are validated, operated and maintained in compliance with EU GMP, FDA, Annex 11, GAMP 5 and applicable regulatory expectations.

Additionally this role supports the lifecycle management of data not only electronically but paper based as well as the cultural maintenance of the Data Integrity and Good Documentation Practices within the site.

Responsibilities

• Must possess a comprehensive understanding of

Computerized Systems Quality Assurance and Data Integrity programs.

• Provide site leadership for Data Integrity governance, strategy, risk management and continuous improvement initiatives.
• Act as the primary QA authority for computerized system validation

(CSV) activities throughout the system lifecycle.

• Ensure Gx P computerized systems remain in a validated state through effective oversight of validation, periodic review and change management activities.
• Lead and coach QA and non QA professionals supporting computerized systems and data integrity activities.
• Review and approve validation plans, user requirements, risk assessments, specifications, test protocols and validation reports.
• Provide QA oversight of computerized systems provided as a service to the site including MES, LIMS, DMS, SAP, Track Wise, Delta V, historian systems and supporting infrastructure.
• Assess and approve changes, deviations, CAPAs and investigations related to computerized systems and data integrity events.
• Drive compliance with EU GMP Annex 11, FDA 21 CFR Part 11, Data Integrity guidance and GAMP 5 principles.
• Lead site inspection readiness for computerized systems and represent QA during customer audits and regulatory inspections.
• Establish and monitor key performance indicators for CSV and Data Integrity programs.
• Partner with business functions to ensure effective governance of electronic records, audit trails, access management and backup/recovery processes.
• Support digital transformation initiatives while ensuring compliance and patient safety.

Requirements

• Bachelor's or Master's degree in Computer Science, Engineering, Pharmaceutical Sciences, Biotechnology, or a related discipline.
• Minimum 5 years of experience in Quality Assurance (QA), Computerized Systems Validation (CSV), IT Quality, Data Integrity, or a related quality/compliance function within a GMP-regulated pharmaceutical, biotechnology, or cell & gene therapy environment, including leadership or project leadership responsibilities.
• Strong expertise in computerized system validation and analytical instrument qualification, including validation lifecycle activities (URS, IQ/OQ/PQ, risk assessments, traceability, testing, validation reports) and risk-based validation approaches.
• Extensive knowledge of Data Integrity principles, governance, testing, and regulatory expectations, including compliance with EU GMP, FDA requirements, Annex 11, 21 CFR Part 11, GAMP 5, and other applicable Gx P regulations.
• Proven experience reviewing and approving validation documentation, deviations, CAPAs, change controls, risk assessments, investigations, and quality records.
• Hands-on experience with regulated Gx P systems and platforms such as MES, LIMS, DMS, SAP, Track Wise/Track Wise AQWA, Kneat, Delta V, Learning Management Systems (LMS), laboratory systems, and manufacturing or automation platforms.
• Experience in deviation management, CAPA management, quality event investigations, root cause analysis (5 Whys, Ishikawa/Fishbone), change control, and risk assessment methodologies.
• Demonstrated experience supporting regulatory inspections, audits, inspection readiness activities, and customer audits.
• Strong understanding of quality systems and compliance processes, including Gx P documentation, SOP authoring and management, training management, gap assessments, supplier qualification, batch record review, product quality review, and quality metrics reporting.
• Experience managing multiple validation and qualification activities simultaneously, including prioritization of high-volume protocol execution and documentation review.
• Proven ability to lead cross-functional teams, drive continuous improvement initiatives, support business process optimization, and effectively collaborate with Quality, IT, Manufacturing, Engineering, Automation, and Laboratory stakeholders.
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