About this role
Senior Associate Director responsible for proactive QA oversight of AbbVie's clinical development programs, ensuring inspection readiness and regulatory compliance across sites.
Key Responsibilities
- Lead collaboration across TAs to ensure best practices
- Lead cross-functional projects and strategies across Therapeutic Areas
- Monitor regulations and industry trends; ensure compliance
- Coordinate internal and external compliance actions, assessments and audits
- Review critical clinical documents with strategic partners
Technical Overview
QA strategy focused on risk management, Quality System Elements, and regulatory alignment; experience with GCP inspections and audits; cross-functional stakeholder engagement.
Ideal Candidate
The ideal candidate is a senior clinical quality professional with 10+ years in pharma QA/regulatory, capable of strategic QA direction and cross-functional collaboration in a large biotech environment.
Must-Have Skills
10+ years pharmaceutical industry experience in any combination of quality assurance/regulatory affairs/clinical research developmentBachelor's degree in a physical sciencelife sciencenursingpharmacy or equivalent technical experience
Nice-to-Have Skills
Leadership in QAinspection readinessglobal regulatory experiencecross-functional collaboration
Required Skills
Quality AssuranceRegulatory ComplianceClinical DevelopmentInspection ReadinessGCPsRDQAQuality System ElementsQuality by DesignRisk ManagementChange ManagementException ManagementAuditcross-functional collaboration
Hard Skills
Quality AssuranceQuality System ElementsQuality by DesignRisk ManagementChange ManagementException ManagementAuditRegulatory complianceRegulationsClinical developmentRDQATherapeutic AreaInspection readinessGCP inspectionsmulti-functional interactionsInspection Ready development programsR&Dcross-functional collaborationQA partners
Soft Skills
Excellent communicationinfluencingpersuasionmatrix managementcollaborationproblem-solvingstakeholder managementleadershipteamworktime management
Keywords for Your Resume
Associate DirectorClinical Quality AssuranceClinical QAQuality Assuranceinspection readinessGCP inspectionsRegulatory complianceRegulationsclinical developmentRDQAQuality System ElementsQuality by DesignRisk ManagementChange ManagementException ManagementAuditcomplianceR&Dmulti-functional interactionsNorth Chicagoassociate directorclinical quality assurancegcp inspectionsregulatory compliance
Deal Breakers
Less than 10 years of pharma QA/regulatory experience, Lack of Bachelor's degree in science
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