Sr. Manager Quality IT
Legendcareers · Bridgewater, New Jersey, United States
About this role
**Legend Biotech — Sr. Manager, Quality IT (Bridgewater, NJ)** **Role Overview** The Sr. Manager, Quality IT provides IT Quality oversight for the implementation and lifecycle management of **GxP IT systems** at Legend Biotech. This role interprets applicable regulations and defines **IT QA requirements**, ensuring processes and procedures comply with regulatory guidelines and company standards—supporting **Electronic Records / Electronic Signatures, Data Integrity, and cGMP/GCP/GLP** expectations (including FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA, and GAMP5). **Key Responsibilities** - Ensure GxP IT systems, processes, and records adhere to **Legend CSV/SDLC** procedures and applicable regulatory requirements. - Provide IT Quality oversight for **system enhancement and validation**, including documentation and change controls. - Contribute to the development and enforcement of **SOPs**. - Partner with cross-functional teams on **system upgrades, maintenance**, and software purchasing recommendations; support user requirements and compliance. - Support development of **Software Validation Plans** and associated IQ/OQ/PQ protocols/reports, **system risk assessments**, SOPs, and **requirements traceability matrices**. - Maintain master files/profiles/tables for software applications and drive **harmonization** across systems. - Review/approve IT **change management** documentation and authorize system use once requirements are met. - Monitor error reports, assure **data integrity**, investigate application problems, and recommend system/procedural improvements. - Support and maintain the **annual IT supplier audit program**; ensure audit observations, deviations, and CAPAs are communicated, tracked, and remediated. - Provide Quality oversight for SOPs governing use and validation of IT systems. - Identify and mitigate risks associated with GxP IT systems and processes. - Train IT personnel and key stakeholders on **GxP computerized system** requirements and standards. - Support continuous improvement via monitoring process performance and metrics. - Assist with inspection readiness and support **GxP regulatory inspections** as required. - Support the regulatory program by monitoring the regulatory landscape and trends. - Support development and gathering of quality metrics for **Quality Management Review (QMR)**. - Operate with minimal direction, using internal contacts for resources; consult leadership for decisions outside established processes. - Provide guidance on quality issues and participate in technical/scientific initiatives. - Recognize and resolve quality issues/data trends; seek guidance on complex topics. - Establish stakeholder relationships across Legend Leadership, functional leads, project management, quality, and IT. **Requirements** - Bachelor’s degree in Science, IT, Engineering, or equivalent technical discipline (**advanced degree preferred**). - **10+ years** relevant experience in pharma/biotech or medical device industries, including **at least 5 years in leadership**. - Experience collaborating and communicating with internal and external stakeholders. - Proficiency with **QMS software, document control, validation tools, change control systems**, and tools such as **LIMS, Veeva, and ERP systems** (SAP a plus). *Note: This posting text was provided in HTML and may be truncated in the source.*
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