Director GMP Quality Assurance

Director, GMP Quality AssuranceLocation: RemoteEmploymentType: Contract (9-12 months+)Hourly Rate - $100-125HRScientific Search has partnered with an innovative biotechnology organization seeking an experienced Director, GMP Quality Assurance to provide strategic and operational QA leadership supporting biologics manufacturing, analytical testing, stability programs, and external partner oversight.This individual will play a key role in ensuring GMP compliance, supporting quality systems, and driving cross-functional collaboration across manufacturing, quality control, regulatory, and supply chain activities within a fast-paced clinical-stage environment.ResponsibilitiesManufacturing & Analytical QA OversightProvide GMP QA oversight for drug substance and drug product manufacturing activities conducted at external CMOs, including batch record review and approvalReview and approve GMP analytical methods, test protocols, and associated documentation generated at external contract laboratoriesProvide quality partnership and oversight for biologics manufacturing, testing, and product disposition activities, including combination productsStability Program QA OversightProvide QA oversight of stability programs for drug substance and drug product activities, including review and approval of stability protocols, reports, and supporting dataPartner with Clinical QC teams to ensure stability study design and execution align with ICH guidelines and applicable regulatory commitmentsReference Standard QA OversightOversee QA activities related to reference standard qualification, characterization, and requalificationReview and approve reference standard protocols and reports while ensuring proper chain of custody, storage, and release documentationGeneral QA & Cross-Functional CollaborationSupport compliance within Quality Management Systems and external CDMO manufacturing/testing operations in accordance with FDA and global GMP regulations, including 21 CFR Parts 4, 210, 211, 820 and EU GMP guidelinesCollaborate cross-functionally with CMC, Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations, and Supply Chain teamsReview and verify quality-related documents, records, protocols, reports, and data supporting biologics programs and productsIdentify, assess, and escalate quality risks while driving compliant resolutions and continuous quality improvement initiativesContribute to the development and refinement of quality processes, procedures, and organizational quality cultureRequirementsBachelor’s degree in scientific discipline or related field required10–15 years of progressive GMP Quality Assurance experience within biotech, pharmaceutical, or biologics environmentsStrong experience overseeing external CDMO/CTO manufacturing and testing operationsHands-on expertise supporting QA oversight of QC operations, manufacturing, analytical testing, and supply chain activitiesStrong working knowledge of FDA and global GMP regulations and quality systemsExperience supporting biologics and/or combination products strongly preferredExcellent communication, collaboration, and problem-solving skills within matrixed organizationsAbility to support occasional evening meetings based on business needsHow To ApplyWe’d love to see your resume, but we don’t need it to have a conversation.Email or message me directly to learn more. - REMOTE