About this role
Senior clinical quality assurance leader responsible for proactive QA oversight of clinical development programs, ensuring inspection readiness and regulatory compliance across R&D.
Key Responsibilities
- Lead collaboration across TAs to ensure best practices
- Lead cross-functional projects and strategies that benefit programs in their Therapeutic Area
- Monitor regulations and industry trends; ensure Compliance with Regulations and Policies
- Coordinate internal and external compliance actions, assessments and audits
- Lead efforts to review critical clinical documents and engage with strategic business partners
Technical Overview
QA strategy focusing on inspection readiness, regulatory compliance, and Quality System Elements; applies Quality by Design to development programs; audits and cross-functional collaboration.
Ideal Candidate
The ideal candidate is a senior Clinical Quality Assurance leader with 10+ years in pharma QA/regulatory functions, capable of leading cross-functional teams and ensuring inspection readiness across clinical development programs.
Must-Have Skills
10+ years pharmaceutical industry experience in 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 ReadinessGCPRegulatory GuidelinesRisk ManagementChange ManagementException ManagementAuditQuality System ElementsQuality by DesignRDQACross-functional collaborationStakeholder management
Hard Skills
Quality AssuranceQuality System ElementsQuality by DesignRisk ManagementChange ManagementException ManagementAuditRegulatory complianceRegulationsClinical developmentRDQATherapeutic AreaInspection readinessGCP inspectionsmulti-functional interactionsInspection Ready development programsRegulatory AffairsR&DCross-functional collaborationQA partners
Soft Skills
Excellent communication (written and oral)influencingpersuasionmatrix managementcollaborationnegotiationleadershipteamworkproblem-solvingadaptability
Keywords for Your Resume
Associate DirectorClinical Quality AssuranceClinical QAQuality Assuranceinspection readinessGCP inspectionsRegulatory complianceRegulationsclinical development programstherapeutic areaRDQAQuality System ElementsQuality by DesignRisk ManagementChange ManagementException ManagementAuditcomplianceR&Dmulti-functional interactionsInspection Ready development programsassociate directorclinical quality assurancegcp inspectionsregulatory complianceclinical developmentrdqaquality system elementsquality by designrisk management
Deal Breakers
Less than 10+ years pharma QA/regulatory experience, Bachelor's degree in science not in required fields
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