Associate Director, CQA Lead Auditor

BioNJ Inc.; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor for a remote role within Regulatory Affairs. The incumbent will support GCP, GLP, and GVP audits, ensure alignment with global regulations, and contribute to inspection readiness and SOP development. May travel up to 25% outside the U.S.

to perform audits. The role reports to the Sr. Director of Clinical Quality Assurance with dotted lines to GCP/GVP AD and GLP Sr.

Qualifications

• Bachelor's degree in biology, biochemistry, or life science.
• Minimum 3 years of 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, CROs.

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
• Coordinate regulatory inspection support activities (FDA, EMA, MHRA, and other Health Authorities)
• Support the risk-based audit program, including audit preparation, execution, reporting, CAPA follow-up and tracking
• 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 comply with GCP, GLP, and GVP requirements
• Support development, maintenance, and periodic review of GxP SOPs, standards, and QMS documentation
• Act as a CQA partner to Clinical and Pre-clinical Functions to support stakeholders with compliance questions and quality improvements
• Audit external vendors providing GLP services including agenda setup, SOP review, and timely filing of reports in Veeva
• Support process of GCP/GLP deviations from study protocols or SOPs
• Collaborate with GLP functions to verify data integrity and compliance with regulations
• Provide quality oversight of contract/internal testing facilities and escalate non-compliance
• Assist with quality metrics, trend analysis, and reporting for risk identification
• Support investigations of compliance issues and quality events with proper escalation
• Deliver training to promote GxP awareness and quality culture
• Provide day-to-day support to CQA functions for process improvements
• Demonstrate knowledge of GCP, GLP, and GVP regulations and guidelines
• Ability to work independently and manage multiple priorities
• Strong written, verbal, and documentation skills
• Willingness to travel domestically and internationally

Skills

GxP auditing

GCP knowledge

GLP knowledge

GVP knowledge

Audit leadership

Regulatory inspections

Documentation

Stakeholder management

English communication

Education

Bachelor's degree in biology/biochemistry/life science

Tools

Veeva system

Job description

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.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice .

Company Information

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.