Sr. Manager, CQA GLP

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Manager/Sr. Manager, GLP – CQA as part of the Regulatory Affairs team based in Somerset, NJ.

Ensure that relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities’ guidance/principles, and/or EDD’s established quality standards. Maintain a compliant quality system to meet requirements and provide overall GLP quality oversight of studies, including assessment of external vendors via audits, onboarding, and laboratory processes. Support the development and review of SOPs, bioanalytical assays required for GLP or CGLP studies, and oversee work performed by external CROs and consultants.

Participate in cross‑functional teams to reinforce a quality culture and contribute to Legend Biotech’s inspection‑readiness goal. The position requires local presence in Somerset, NJ, and a hybrid work schedule (2‑3 days onsite).

• Support the GLP quality compliance systems via established policies and procedures for the GLP QA function.
• Manage GLP quality systems, including implementation and maintenance of procedures and standards, and support documentation review activities to ensure compliance.
• Support or perform audits of external vendors providing GLP related services, including agenda setup, confirmation letters, review of vendor SOPs, and timely filing of audit reports and related documentation in the Veeva system.
• Support the process of GCP/GLP deviations from study protocols or standard operating procedures.
• Support internal and external GLP study audits and general laboratory compliance audits to ensure laboratories adhere to all quality protocols and regulations.
• Collaborate with relevant GLP functions in reviewing data for nonclinical and clinical studies to verify data integrity and compliance with protocols and regulations.
• Provide quality oversight of contract or internal testing facilities to ensure adherence to all regulations, standard procedures, and protocols; alert management of non‑compliance issues and elevate concerns when necessary.
• Support development of agenda items for Early Development (EDD) team meetings to provide input and quality perspectives.
• Provide input in the development of GLP related SOPs, and support cross‑functional teams in development of quality related documentation (e.g., SOPs, training modules).
• Communicate activities and feedback to the core Quality management team to allow other members to identify issues or action items.
• Contribute to GLP audits/inspections and coordinate the review of responses to regulatory agency questions resulting from inspections or audits.

• Bachelor’s degree in biology, biochemistry, or a life science discipline.
• Proficient communication skills in English.
• Minimum of 3 years (for Sr. Manager) or 1 year (for Manager) of related industry experience in Quality.
• At least 3 years of experience working with or overseeing GLP quality in laboratories testing biologics.
• Experience performing audits of GLP testing labs (preferred).
• Experience participating in and hosting regulatory audits (preferred).
• Experience working with CROs, vendors, and relationship management.
• Experience in auditing activities.
• Ability and desire to collaborate with diverse employees and customers.
• Team player with strong interpersonal skills and a forward‑thinking, pragmatic approach to quality.
• Strong project management skills.
• Abili…