Sr. Manager, CQA Lead Auditor

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor as part of the Regulatory Affairs team based Remotely. 

Role Overview

The incumber will support the execution of GxP audit and inspection activities across GCP, GLP, GCLP and GVP, ensuring compliance with applicable global regulations and internal quality standards, while contributing to inspection readiness, SOPs development, and continuous quality improvement initiatives. The incumbent may be assigned to perform audits outside the U.S.A. (max 25% of the time).

Key Responsibilities

• Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member, including internal processes, investigator sites, internal and external GLP study audits and general laboratory compliance audits vendors, and service providers
• Contribute to / coordinate regulatory inspection support activities (e.g., FDA, EMA, MHRA, and other Health Authorities), including preparation, coordination, and follow-up actions.
• Support the risk-based audit program, including audit preparation, execution, reporting, and CAPA follow-up and tracking and effectiveness checks.
• Document audit observations, assess responses, and review CAPA evidence for adequacy and timely closure.
• Provide quality and compliance support to ensure clinical, non-clinical, and pharmacovigilance activities are conducted in accordance with GCP, GLP, and GVP requirements.
• Support the development, maintenance, and periodic review of GxP SOPs, written standards, and QMS documentation.
• Act as a CQA partner to the Clinical and Pre-clinical Functions to support the stakeholders by advising on compliance questions, issue resolution, and quality improvement actions.
• Support/perform audits of external vendors that provide GLP related services. The ‘audit’ includes all activities, from the set up of the agenda, confirmation letter, review of vendor’s SOPs, etc. to the timely (30 days’ target) filing of the audit report and other relevant documentation in the Veeva system.
• Support the process of GCP/GLP deviations from study protocols or standard operating procedures.
• Collaborate with the GLP’s relevant functions in reviewing relevant data for nonclinical and clinical studies to verity data integrity and to ensure work was performed according to protocols and complied with all relevant regulations.
• Provide quality oversight of contract or internal testing facilities to ensure adherence to all regulations, standard procedures and protocols. Alert the appropriate level of management with any non-compliance issues, ensure all corrective actions take place and elevate concerns when necessary.
• Assist with quality metrics, trend analysis, and reporting to support identification of compliance risks and areas for improvement. 
• Support investigations of compliance issues, serious breaches, or quality events, escalating issues as appropriate.
• Deliver training and coaching to business functions to promote GxP awareness and a strong quality culture.
• Provide day-to-day support to applicable CQA functional line related to process improvements and harmonization with regulations.
• Working knowledge of GCP, GLP, and GVP regulations and guidelines.
• Ability to support and perform audits using a risk-based approach.
• Good stakeholder management and communication skills.
• Ability to work independently on assigned tasks with appropriate supervision.
• Strong written, verbal, and documentation skills.
• Organized, detail-oriented, and able to manage multiple priorities.
• Willingness to travel domestically and internationally as required.

The incumbent will report to the Sr. Director of Clinical Quality Assurance, and dotted line to the GCP/GVP AD, and to the GLP Sr. Manager.

Requirements

• Bachelor’s degree in biology, biochemistry, or the life science.
• Must be able to communicate effectively in English.
• A minimum of 3 years of related industry experience in Quality in the Pharmaceutical industry.
• 3 years of experience in working and/or overseeing GCP, GVP and GLP Quality in laboratories testing biologics, as well as CROs.
• Experience performing audits of GLP testing labs is a plus.
• Experience with participation in and hosting regulatory audits.
• Experience working with CROs, vendors, and relationship management.
• Ability and desire to work well with diverse employees and customers in a cooperative and supportive manner.

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