Quality Control Lead

The ideal candidate must have experience supporting regulatory submission readiness, with a strong focus on tracking QC deliverables, testing schedules, and resource loading to ensure all activities align with the Client’s July 2026 BLA filing commitment.

This role is responsible for establishing QC programs and ensuring GMP-compliant testing and release of materials, intermediates, and finished products under FDA, EU, and international regulations. The candidate will lead laboratory investigations (OOS, OOT, OOE), support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

• Utilize project management tools to track QC testing deliverables, ensuring execution aligns with the July 2026 BLA submission timeline.
• Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
• Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
• Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
• Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
• Author technical documents including SOPs, test methods, method validation protocols/reports, and material specifications.
• Lead investigations for OOS, OOT, OOE results, ensuring thorough root-cause analysis and compliant documentation.
• Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
• Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
• Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.
• Perform additional duties as required to support QC, compliance, and BLA submission needs.

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or related scientific discipline.
• 7–12 years of experience in an FDA-regulated pharmaceutical or biotechnology environment, with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).

• Proficiency with analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
• Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
• Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
• Proven experience tracking testing deliverables, coordinating QC schedules, and supporting regulatory timelines.
• Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.