VAM Systems is currently looking for a Manager – Quality and Cross IT Applications for our UAE operations, with the following skill set and terms and conditions:
Qualifications:
- Bachelor’s Degree with 10+ years of IT Quality, computerized systems compliance, and SDLC experience in life sciences/manufacturing.
- Key quality (GxP) certifications preferred.
Main Responsibilities:
- Ensure proper documentation and validation of computerized systems.
- Serve as SME on SDLC / Qualification procedures and provide CSV guidance to IT and Business teams.
- Maintain alignment and compliance of IT quality with organizational strategies, goals, and standards such as ISO, CMMI, ITIL.
- Lead the team handling IT GMP and Non-GMP validation audits, both internal and external.
- Coordinate with cross-disciplinary teams to meet project requirements and deadlines.
- Plan and conduct audits of IT processes, products, and services, reporting findings and recommendations.
- Manage corrective and preventive actions ensuring their effectiveness.
- Set up steering and project committees, and communicate with stakeholders.
- Facilitate communication within global teams, resolve conflicts, escalate issues, and seek resolutions.
- Oversee sign-offs and training completion within project timelines.
- Review and prepare validation documents and maintain IT policies/SOPs (GMP/Non-GMP).
- Provide training and coaching on IT policies, SOPs, and best practices.
- Analyze validation data and recommend improvements.
- Support audits to ensure compliance with standards and regulations.
- Perform periodic validation reviews and re-qualifications.
- Manage IT CAPAs, deviations, change controls, and contracts for GMP solutions.
- Conduct gap analyses and develop remediation plans, including CAPA processes.
- Manage IT change controls, incident, and deviation management processes.
- Collaborate closely with user departments and suppliers for support.
- Understand GxP, automation, and compliance roles.
- Apply and implement standards like ISO, CMMI, ITIL, and pharma regulations such as CFR Part 11.
- Experience with SAP ECC, S4HANA, GxP, GMP, reporting tools, and EQMS solutions.
- Technical documentation writing experience.
- Knowledge of GAMP5 and risk-based validation approaches.
- Review validation deliverables and project documentation.
- Identify and propose quality framework improvements.
- Excellent communication, presentation, and interpersonal skills.
- Experience in Pharma/Biotech industries.
- Manage projects from initiation to completion in quality compliance.
- Participate in cross-functional validation/verification activities.
- Proven experience with IT risk management and controls.
- Proficiency in MS Office and documentation lifecycle practices.
- Experience with SOX IT controls.
Joining time frame: 15-30 days
Position: IT Manager • Dubai, United Arab Emirates