Biotech Project Management Jobs in Elizabeth, NJ

Legend Biotech is seeking a Sr Manager, Quality IT as part of the Quality IT team based in Bridgewater, NJ.

Role Overview

The Sr Manager, Quality IT is responsible for providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines

Key Responsibilities

• Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements. 
• Provide IT Quality oversight for GxP System enhancement and validation activities inclusive of documentation and change controls. 
• Contribute to the development and enforcement of applicable standard operating procedures at Legend. 
• Work with cross-functional teams for System upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance. 
• Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and reports; System Risk Assessments, Standard Operating Procedures; and Requirements Traceability Matrices. 
• Maintain master files, profiles and tables for multiple software applications and drive harmonization across systems. 
• Review and approve IT systems change management documentation, authorizing system use upon verification that requirements are met. 
• Monitor error reports and assure data integrity. Investigate and document application problems and recommend system and/or procedural changes. 
• Support and maintain the annual IT supplier audit program. 
• Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated, in compliance with internal policies and procedures as well as with all applicable regulatory requirements. 
• Provide Quality oversight for SOPs governing use and validation of IT Systems. 
• Identify and mitigate risks associated with GxP IT systems and processes, developing strategies to address compliance risks. 
• Train IT personnel and key stakeholders on GxP requirements and standards for computerized systems. 
• Support continuous improvement efforts through the monitoring of process performance and metrics. 
• Assist with inspection readiness efforts and program implementation and support GxP regulatory inspections as required. 
• Support Legend's regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments. 
• Support development and gathering of quality metrics for Legend's Quality Management Review (QMR). 
• Require minimal directions to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues or data trends. Seek management guidance on complex issues.
• Ability to quickly process complex information and often make critical decisions with limited information with minimal oversight.
• Establish key stakeholder relationships with all Legend Leadership Team, Legend Functional Leads, Legend Project Management, Legend Quality and Legend IT. 

Requirements

• A minimum of a Bachelor's degree in Science, IT, Engineering or equivalent technical discipline. Advanced degree preferred.
• 10+ years of relevant work experience within a pharmaceutical / biotech or medical device industry with min 5 yrs leadership experience is required.
• Experience collaborating and communicating effectively with internal and external stakeholders
• Proficiency in QMS software, document control, validation tools, change control systems, LIMS, Veeva, ERP systems (SAP considered a plus)
• Ability to clearly represent compliance requirements and drive continuous improvement following risk-based approaches
• Highly motivated, flexible, and excellent organizational skills
• Experience working in Quality Assurance, Quality Systems and/or IT
• Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus)
• Excellent verbal and written communication skills
• Ability to prioritize and balance work from multiple projects in parallel
• Regulatory Agencies firsthand inspection experience considered a plus
• Clinical, GMP and GLP audit experience considered a plus

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