Senior IT Quality & Compliance Manager (GxP)

BioSpace; Bridgewater (MA); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Paid parental leave

Paid time off

Well-being programs

Job summary

Legend Biotech, based in Bridgewater, NJ, is hiring a Sr Manager, Quality IT to lead IT quality oversight for GxP systems and ensure compliance with FDA, EU Annex 11, and other regulations. You will define QA requirements, manage validation, change control, SOPs, audits, and support inspections, with cross-functional teams to maintain data integrity and system readiness.

This role requires 10+ years in pharma/biotech, strong leadership, and deep knowledge of global GxP guidelines; US work

Qualifications

• Bachelor’s degree in Science, IT, Engineering or equivalent technical discipline.
• 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.

Responsibilities

• 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; 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.

Skills

Leadership experience

Regulatory knowledge

Quality Assurance

Communication skills

GxP expertise

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Science/IT/Engineering

Advanced degree preferred

Tools

QMS software

Document control

Validation tools

Change control systems

LIMS

Veeva

ERP systems (SAP)

Job description

Legend Biotech, based in Bridgewater, NJ, is hiring a Sr Manager, Quality IT to lead IT quality oversight for GxP systems and ensure compliance with FDA, EU Annex 11, and other regulations. You will define QA requirements, manage validation, change control, SOPs, audits, and support inspections, with cross-functional teams to maintain data integrity and system readiness.

This role requires 10+ years in pharma/biotech, strong leadership, and deep knowledge of global GxP guidelines; US work