Associate Director, R&D Quality Assurance

SummaryOur client, a first-in-class biopharmaceutical client located in Southern California, is seeking an Associate Director, R&D Quality Assurance (Early-Stage Development) to support their expanding pipeline. This individual will lead quality assurance activities for early-phase clinical development, working cross-functionally to ensure compliance, manage vendor relationships, and mitigate risk across development programs. This role operates in a fast-paced, high-performing environment and requires strong collaboration, technical expertise, and the ability to operate under pressure as an individual contributor.Duties / Expectations of RoleQuality Assurance LeadershipLead and oversee QA activities for early-stage (preclinical through Phase I/II) development programsDevelop, implement, and maintain Quality Management Systems (QMS) supporting early developmentEnsure compliance with global GxP regulations (GCP, GLP, GMP) and internal standardsServe as QA representative on cross-functional project teamsCross-Functional CollaborationProvide QA guidance to Clinical, Regulatory, Analytical Development, Supply Chain, and CMC teamsAdvise on risk mitigation strategies across programsParticipate in internal and external operational and vendor meetingsVendor & External Partner ManagementOversee contract manufacturers (CMOs), testing labs, packagers, raw material suppliers, and warehousesSupport vendor qualification, audits, and quality agreementsTroubleshoot manufacturing issues and collaborate with vendors on resolutionQuality Systems & DocumentationReview and approve: Investigations (deviations, OOS, production issues)Change controls (MMRs, test methods)Validation protocols and reportsBatch records (master and executed) and product dispositionContribute to SOPs, protocols, reports, and regulatory submissionsOperational ResponsibilitiesParticipate in blinded clinical study support (2–3 arms)Manage and approve batch release for clinical trial materialsSupport analytical documentation and validation processesCandidate Profile & FitMust-Have Qualifications12+ years of experience (or 7+ years with advanced degree) in Pharma QAStrong experience across early development (formulation → Phase I → Phase II)Experience with sterile manufacturing (e.g., ointments, sterile products)Experience working with CMOs, testing labs, and cross-functional teamsStrong knowledge of quality requirements across development phasesExperience troubleshooting and resolving vendor/manufacturing issuesBachelor’s degree in a scientific disciplineAbility to work under pressure and extended hours when neededComfortable operating as an individual contributor initiallyStable background with strong track record in reputable organizationsNice-to-Have QualificationsExperience taking products through commercializationMaster’s degreeTablet manufacturing experienceExperience supporting regulatory submission writingTerm & StartFull-time, permanent roleHybrid: 3 days onsite (Irvine, CA)Preference for candidates in San Diego or West Coast time zoneTravel: ~15% (including quarterly onsite “anchor week”)Start: ASAPFull client benefits, bonus, and stock options