Orbital Therapeutics
Senior Manager/Associate Director, GMP Quality Assurance
Orbital Therapeutics, Cambridge, Massachusetts, us, 02140
Senior Manager/Associate Director, GMP Quality Assurance
Orbital Therapeutics is advancing a new generation of RNA medicines designed to reprogram cells in vivo, treating diseases at their source. The companys lead program, OTX-201, targets autoimmune disease through B cell depletion to reset the immune system. Orbitals platform spans circular and linear RNA, targeted delivery, and AI-guided design, with plans to expand into broader autoimmune indications, oncology, next-generation vaccines, and protein therapeutics. JOB SUMMARY The Senior Manager/Associate Director, Quality Assurance will establish and maintain GMP compliance across Orbitals manufacturing and quality systems. This role includes hands-on batch record review, QMS management (Veeva), vendor oversight, and audit preparation to ensure regulatory requirements are met. The role may expand into GCP and GLP responsibilities as Orbital progresses into clinical development. RNA/LNP experience is strongly preferred. Responsibilities Serve as the primary internal GMP QA lead, ensuring compliance with FDA, EU, and other regulatory authorities. Manage and maintain Orbitals electronic Quality Management System (Veeva), including change controls, deviations, and CAPAs. Conduct detailed technical review of GMP manufacturing batch records, validation reports, stability data, and product release documentation. Oversee vendor quality, including contract manufacturers, through audits, quality agreements, and issue resolution. Support qualification of contract manufacturing/testing sites and distribution depots. Participate in audits (domestic and international) to assess compliance status and mitigate risks. Collaborate cross-functionally with CMC and Regulatory teams to ensure timely, accurate quality deliverables. Provide input into long-term quality strategy, with an initial focus on GMP and an opportunity for future growth into GCP/GLP oversight.
Qualifications
B.S. or M.S. in a scientific discipline. 68 years of biopharma experience, with at least 4 years of GMP QA experience in a manufacturing/CMC setting. RNA/LNP product experience strongly preferred. Experience with batch record review, vendor management, and QMS (Veeva strongly preferred). Familiarity with FDA and EU GMP regulations; GCP/GLP exposure a plus. Hands-on, detail-oriented, with ability to thrive in a lean, fast-paced biotech environment. Strong communication and interpersonal skills for effective cross-functional collaboration.
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Orbital Therapeutics is advancing a new generation of RNA medicines designed to reprogram cells in vivo, treating diseases at their source. The companys lead program, OTX-201, targets autoimmune disease through B cell depletion to reset the immune system. Orbitals platform spans circular and linear RNA, targeted delivery, and AI-guided design, with plans to expand into broader autoimmune indications, oncology, next-generation vaccines, and protein therapeutics. JOB SUMMARY The Senior Manager/Associate Director, Quality Assurance will establish and maintain GMP compliance across Orbitals manufacturing and quality systems. This role includes hands-on batch record review, QMS management (Veeva), vendor oversight, and audit preparation to ensure regulatory requirements are met. The role may expand into GCP and GLP responsibilities as Orbital progresses into clinical development. RNA/LNP experience is strongly preferred. Responsibilities Serve as the primary internal GMP QA lead, ensuring compliance with FDA, EU, and other regulatory authorities. Manage and maintain Orbitals electronic Quality Management System (Veeva), including change controls, deviations, and CAPAs. Conduct detailed technical review of GMP manufacturing batch records, validation reports, stability data, and product release documentation. Oversee vendor quality, including contract manufacturers, through audits, quality agreements, and issue resolution. Support qualification of contract manufacturing/testing sites and distribution depots. Participate in audits (domestic and international) to assess compliance status and mitigate risks. Collaborate cross-functionally with CMC and Regulatory teams to ensure timely, accurate quality deliverables. Provide input into long-term quality strategy, with an initial focus on GMP and an opportunity for future growth into GCP/GLP oversight.
Qualifications
B.S. or M.S. in a scientific discipline. 68 years of biopharma experience, with at least 4 years of GMP QA experience in a manufacturing/CMC setting. RNA/LNP product experience strongly preferred. Experience with batch record review, vendor management, and QMS (Veeva strongly preferred). Familiarity with FDA and EU GMP regulations; GCP/GLP exposure a plus. Hands-on, detail-oriented, with ability to thrive in a lean, fast-paced biotech environment. Strong communication and interpersonal skills for effective cross-functional collaboration.
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