Senior Manager/Associate Director, GMP Quality Assurance (Contract)

JOB SUMMARY 

The Contract Senior Manager/Associate Director, Quality Assurance will be responsible for establishing and maintaining GMP compliance across Orbital’s manufacturing and quality systems. This role will provide hands-on execution in batch record review, QMS management (Veeva), vendor oversight, and audit preparation, ensuring Orbital’s products meet regulatory requirements. While the immediate focus is GMP, the role is designed to expand into GCP and GLP responsibilities as Orbital progresses into clinical development. Candidates with RNA/LNP experience are strongly preferred. 

RESPONSIBILITIES: 

• Serve as the primary internal GMP QA lead, ensuring compliance with FDA, EU, and other regulatory authorities.
• Manage and maintain Orbital’s 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.
• 6–8 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 the ability to thrive in a lean, fast-paced biotech.
• Strong communication and interpersonal skills for effective cross-functional collaboration.