The IT Quality Operations Manager is responsible for ensuring that quality records that support IT/Computerized Systems are in compliance with industry regulations, internal procedures and industry best practices.
Provide guidance to maintain established GxP computerized system throughout their life cycle.
Ensure the timely review and approval of quality systems records to meet department and corporate metrics.
Communicate with all levels of the organization, execution teams and compliance stakeholders to assure that Quality deliverables are sufficiently planned and executed within specified timelines.
Support daily Quality Assurance Operations, including but not limited to, creation, revision and implementation of documentation to support Computer Systems operations.
Support for Quality Improvement Plans, including the creation and revision of SOPs to improve the existing SDLC and Computer Systems Validation Programs.
This role may be required to support Computer Systems Validation projects, wherein the individual will review and approve computer system validation deliverables to meet demand, as appropriate.
• The IT Quality Operations Manager has thorough knowledge of global regulatory requirements for computer systems validation, including ERES (Part 11 and Annex 11) and predicate rules.
• The Technical knowledge of TrackWise and ServiceNow preferred
• Extensive knowledge of QMS, including Deviations, CAPAs, Effectiveness Checks, Change Controls.
• Analytical thinker who can think able to identified problems and use critical thinking to identify root cause. Formal root cause analysis training, preferred.
• High-level understanding of IT infrastructure qualifications and computer systems validation best practice principles.
• Skilled in Technical Writing.
• High-level knowledge of computer systems interfaces, architecture and design.
• Excellent communication style that assures clear and concise communications.
• Experience in working with geographically and culturally diverse teams, preferred.
• 5-7 years of direct QA oversight experience for QMS support for GxP IT/Computerized Systems.
• 3-5 years of CAPA and deviation management experience using TrackWise
• 3-5 years of change management experience using TrackWise
• 2-4 years of experience technical writing
• 2-4 years of experience reviewing computer systems validation deliverables from a quality perspective
• 3-5 years in a GxP in biopharmaceutical / pharmaceutical industry.
• Knowledge of GAMP5, System Development Life Cycle (SDLC) and IT infrastructure, including SaaS, data quality, data integrity and data management best practices.
• BS/BA degree in Engineering, Chemistry, Biology and/or science related field; advanced degrees preferred.
Joy Provenzano, VP- Recruiting, The Judge Group
Let’s connect on linkedin: http://www.linkedin.com/in/joyprovenzano
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