✦ Luna Orbit — Healthcare & Medical

Associate Director, Clinical Quality Assurance

at AbbVie

📍 Worcester, MA Hybrid Posted April 02, 2026
Type Full-Time
Experience lead
Exp. Years 10+ years
Education Bachelor's degree in a physical science, life science, nursing, pharmacy or equivalent technical experience
Category Healthcare & Medical

Associate Director, Clinical Quality Assurance leads proactive quality oversight of clinical development programs, ensuring GxP compliance and inspection readiness while coordinating audits and building robust QA processes across R&D.

  • Lead collaboration across TAs to ensure best practices; Lead cross-functional projects and strategies; Monitor new regulations and ensure compliance; Coordinate internal and external compliance actions and audits; Lead risk management and QA communications

Role emphasizes QA leadership in clinical development environments, with focus on GxP compliance, regulatory affairs, audits, validation, and cross-functional collaboration.

The ideal candidate is a senior QA/Regulatory affairs executive with 10+ years in pharma, leading cross-functional clinical QA initiatives, ensuring inspection readiness and regulatory compliance across R&D and manufacturing.

Bachelor's degree in a physical sciencelife sciencenursingpharmacy or equivalent technical experience10+ years of pharmaceutical industry experience in quality assurance/regulatory affairs/clinical research developmentStrong leadership skillsCritical thinking with strategic QA solutionsAgility to respond to unplanned events and regulatory changesExcellent written and oral communicationinfluencing and collaboration
GxP certificationsIT validation certifications
GxPLIMSELNCTMSMESdata platformsQAregulatory complianceinspection readinessrisk managementchange managementaudit support
GxPRegulatory complianceInspection readinessQuality System ElementsRisk ManagementChange ManagementAudit support
LeadershipCommunicationInfluencingCollaborationStrategic thinkingNegotiationProblem solving

Preferred

GxP compliance certificationsRegulatory affairs certifications
Industry Healthcare & Medical
Job Function Strategic quality assurance leadership for clinical development programs
Role Subtype Clinical QA Lead
Associate DirectorClinical Quality Assuranceclinical qaGxPLIMSELNCTMSMESdata platformsQAregulatory affairsinspection readinessaudit readinessregulatory compliancechange managementrisk managementvalidationclinical developmentQA teamsR&Dclinical quality assuranceauditsvendor managementleadership

Lack of 10+ years pharma QA/regulatory experience, No experience with GxP systems or regulatory audits, Inability to lead cross-functional teams

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