Sr. Manager, CQA GLP
Legend Biotech
June 28, 2026
Remote friendly (Somerset, NJ)
United States
Operations
Role Overview
- Ensure relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities’ guidance/principles and/or EDD quality standards.
- Maintain a compliant quality system; provide overall GLP quality oversight of studies, including assessment of external vendors via audits to onboarding.
- Oversee laboratory processes by reviewing/supporting SOP development and supporting bioanalytical assays for GLP/CGLP studies.
- Support oversight of external CROs/consultants.
- Partner with study teams on GCP/GLP processes to reinforce a quality culture; support inspection-readiness.
Key Responsibilities
- Support GLP quality compliance systems and GLP QA policies/procedures.
- Manage GLP quality systems (implement/maintain procedures/standards) and support documentation review.
- Support/perform GLP-related vendor audits (agenda through SOP review; file audit reports in Veeva within 30 days).
- Support GCP/GLP deviations from protocols or SOPs.
- Support internal/external GLP audits and laboratory compliance audits.
- Collaborate to review nonclinical/clinical data for data integrity and protocol/regulatory compliance.
- Provide quality oversight of internal/contract testing facilities; manage non-compliance and corrective actions.
- Support EDD meeting agenda development with quality input.
- Provide input to GLP SOPs and quality-related documentation (e.g., training modules).
- Communicate quality activities/feedback to the core Quality management team.
- Contribute to GLP audits/inspections and coordinate responses to regulatory questions.
Requirements
- Bachelor’s degree in biology, biochemistry, or life sciences.
- English communication skills.
- Experience: Sr. Manager—3+ years; Manager—1+ year in Quality; 3+ years overseeing/working with GLP Quality in biologics testing.
- Plus: GLP lab audit experience; participation/hosting regulatory audits; CRO/vendor experience.
- Audit experience; strong project management; ability to articulate QA-GLP perspective.
- Working knowledge of FDA and ICH GCP/GLP regulations.
Benefits (as stated)
- Base pay range: $146,410–$192,164.
- Performance-based bonus and/or equity (eligible roles).
- Medical/dental/vision; 401(k) with full vesting day one; paid parental leave (8 weeks after 3 months); paid time off (vacation/personal/sick/floating holidays) and 11 company holidays; other voluntary benefits.
- Note: benefits only for permanent full-time employees (contractors not eligible).
- Ensure relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities’ guidance/principles and/or EDD quality standards.
- Maintain a compliant quality system; provide overall GLP quality oversight of studies, including assessment of external vendors via audits to onboarding.
- Oversee laboratory processes by reviewing/supporting SOP development and supporting bioanalytical assays for GLP/CGLP studies.
- Support oversight of external CROs/consultants.
- Partner with study teams on GCP/GLP processes to reinforce a quality culture; support inspection-readiness.
Key Responsibilities
- Support GLP quality compliance systems and GLP QA policies/procedures.
- Manage GLP quality systems (implement/maintain procedures/standards) and support documentation review.
- Support/perform GLP-related vendor audits (agenda through SOP review; file audit reports in Veeva within 30 days).
- Support GCP/GLP deviations from protocols or SOPs.
- Support internal/external GLP audits and laboratory compliance audits.
- Collaborate to review nonclinical/clinical data for data integrity and protocol/regulatory compliance.
- Provide quality oversight of internal/contract testing facilities; manage non-compliance and corrective actions.
- Support EDD meeting agenda development with quality input.
- Provide input to GLP SOPs and quality-related documentation (e.g., training modules).
- Communicate quality activities/feedback to the core Quality management team.
- Contribute to GLP audits/inspections and coordinate responses to regulatory questions.
Requirements
- Bachelor’s degree in biology, biochemistry, or life sciences.
- English communication skills.
- Experience: Sr. Manager—3+ years; Manager—1+ year in Quality; 3+ years overseeing/working with GLP Quality in biologics testing.
- Plus: GLP lab audit experience; participation/hosting regulatory audits; CRO/vendor experience.
- Audit experience; strong project management; ability to articulate QA-GLP perspective.
- Working knowledge of FDA and ICH GCP/GLP regulations.
Benefits (as stated)
- Base pay range: $146,410–$192,164.
- Performance-based bonus and/or equity (eligible roles).
- Medical/dental/vision; 401(k) with full vesting day one; paid parental leave (8 weeks after 3 months); paid time off (vacation/personal/sick/floating holidays) and 11 company holidays; other voluntary benefits.
- Note: benefits only for permanent full-time employees (contractors not eligible).