Job Description Our large pharmaceutical client is seeking an experienced Quality Specialist to support and oversee operations at an external manufacturing partner within the Advanced Therapeutics network. This role is critical to ensuring uninterrupted, compliant manufacturing of CAR T, cell therapy, or other advanced therapeutic modalities.The ideal candidate demonstrates a deep understanding of batch review and release, exceptional deviation impact assessment capability, and strong root cause analysis skills. This person must be able to navigate a complex, fast-paced environment while making sound decisions with limited information. A strong understanding of manufacturing criticality, flexibility to support batch release timelines, and a solid knowledge base of the platform are essential. Key Responsibilities • Serve as the sponsor’s on-site Quality Representative and primary point of contact for all manufacturing quality decisions. • Perform real-time, daily oversight of external manufacturing activities to ensure compliance with cGMPs and sponsor expectations. • Conduct thorough batch record reviews and manage batch release activities with a strong understanding of critical manufacturing parameters. • Lead and support investigations, including deviation impact assessments and root cause analysis, ensuring timely and effective resolution. • Review and assess change controls, complaints, procedures, and associated documentation. • Monitor batch progress, proactively identify risks, and adjust schedules as needed to support timely release. • Provide quality oversight, drive adherence to compliance standards, and work to minimize non-conformances. • Support audits, inspections, and readiness activities at the external manufacturing site. • Ensure alignment with safety and quality policies while fostering a culture of quality and continuous improvement. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements • Bachelor’s degree in a scientific discipline. • At least 5 years of experience within external quality manufacturing in the pharmaceutical or biotechnology industry. • Previous experience working with CAR T, cell therapy, or other advanced therapeutic modalities. • Demonstrated strength in Root Cause Analysis within a regulated pharmaceutical environment. • Experience with Change Management and Deviation Management. • Ability to work independently, manage competing priorities, and navigate time sensitive environments. • Strong interpersonal, verbal, and written communication skills, with the ability to collaborate across functions. • Proven ability to quickly process complex information and make critical decisions with limited data.