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 develop 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. We apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen (Johnson & Johnson) to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel) for the treatment of multiple myeloma.

Regulatory Affairs – Somerset, NJ

The incumbent will ensure that nonclinical studies are performed in compliance with GLP regulations and health authorities’ guidance. The role maintains a compliant quality system, oversees GLP quality oversight of studies, audits external vendors, and supports SOP development and bioanalytical assays for GLP or CGLP studies. The appointee may oversee work performed by external CROs and consultants, support GCP/ICH guidelines, and partner with study teams to reinforce a quality culture and inspection‑readiness.

The role is local to Somerset, NJ and operates on a hybrid schedule. The incumbent reports to the Sr. Director of Clinical Quality Assurance.

• Support GLP quality compliance systems, implementing and maintaining procedures and standards.
• Manage GLP quality systems, including documentation review activities to ensure compliance.
• Perform audits of external vendors providing GLP services, complete audit reports within 30 days, and record findings in the Veeva system.
• Manage GCP/GLP deviations from study protocols or SOPs.
• Support internal and external GLP study audits and laboratory compliance audits to ensure adherence to all quality protocols and regulations.
• Collaborate with GLP functions to review data for nonclinical and clinical studies, verifying data integrity and compliance with protocols.
• Provide quality oversight of contract or internal testing facilities, alert managing levels with non‑compliance issues, ensure corrective actions, and elevate concerns when necessary.
• Support development of agenda items for Early Development (EDD) team meetings, providing quality perspectives.
• Provide input on GLP‑related SOPs and support cross‑functional teams in developing quality‑related documentation such as SOPs and training modules.
• Communicate activities and feedback to the core Quality management team to identify issues or action items.
• Contribute to GLP audits/inspections, coordinate the review of responses to regulatory agency questions, and support external/internal audit activities.

• Bachelor’s degree in biology, biochemistry, or life sciences.
• Proficient English communication skills.
• Minimum of 1 year of quality industry experience for Manager level (3 years for Sr. Manager).
• 3 years of experience working in or overseeing GLP quality labs testing biologics.
• Experience performing audits of GLP testing labs (plus).
• Experience participating in or hosting regulatory audits (plus).
• Experience working with CROs, vendors, and relationship management.
• Experience in auditing activities.
• Ability to work well with diverse employees and customers cooperatively.
• Team player with good interpersonal skills, forward‑thinking, and pragmatic problem‑solving oriented towards quality.
• Strong project management skills.
• Ability to articulate QA‑GLP perspective and status of QA activities at cross‑functional meetings.
• Working knowledge of FDA, ICH GCP guidelines, and GCP/GLP related regulations.
• Results driven with demonstrated successful outcomes.

Base pay range: $146,410 – $192,164 USD. Performance‑based bonus and/or equity is available to eligible employees.

Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; 8 weeks of paid parental leave after 3 months; paid time off policy including vacation, personal, sick, floating…