About this role
Senior Quality Engineer, Risk Management at AbbVie focuses on QA activities for TPM plants, investigations, and regulatory submissions, ensuring GMP compliance and CAPA effectiveness across site operations.
Technical Overview
QA-focused role with GMP/cGMP, regulatory compliance, LIMS/SAP/LRMS experience, CAPA, investigations, and product quality reviews in pharmaceutical/biologics contexts.
Ideal Candidate
The ideal candidate is a senior quality engineer with deep experience in TPM/TPM environments, GMP/cGMP familiarity, and a track record of regulatory compliance and CAPA investigations, capable of leading cross-functional QA activities in a biologics/pharma setting.
Must-Have Skills
Bachelor's Degree in Physical or Life SciencesPharmacyor Engineering15+ years of combined experience in ManufacturingQAQCR&D in pharmaceuticalbiologicsdevice or chemical industryMust have a basic understanding and working knowledge of the physical and chemical characteristics of the productsMust be familiar with statistical quality systemselectronic document management and laboratory information managementMust have effective people management and communication skills
Nice-to-Have Skills
Certified Quality EngineerExperience with AI applications and their deployment at enterprise scaleExperience managing large projects within a complex matrixed organization
Tools & Platforms
LIMSLRMSSAPElectronic Document Management System (EDMS)
Required Skills
Bachelor's Degree in Physical or Life SciencesPharmacyor Engineering15+ years of experience in ManufacturingQAQCR&D in pharma/biologics/device/chemicalknowledge of GMP/cGMPregulatory complianceLIMS/SAP/LRMSdata management
Hard Skills
Quality SystemscGMPFDA regulationsEU regulationsRegulatory ComplianceBudget ManagementTeam LeadershipQuality AssuranceQuality ControlLIMSElectronic Document ManagementStatistical Quality SystemsSAPLRMSLaboratory Information Management System
Soft Skills
Strong communicationInterpersonal skillsLeadershipCross-functional collaborationProblem-solving
Certifications
Preferred
Certified Quality Engineer
Keywords for Your Resume
Senior Quality EngineerRisk ManagementThird Party ManufacturingTPMQuality SystemscGMPGMPCAPALRMSLIMSSAPRegulatory complianceInvestigationProduct Quality ReviewPQRchange managementregulatory submissionsQAQuality AssuranceRegulatory requirementssenior quality engineerrisk managementtpmcgmpgmpcapalimssaplrms
Deal Breakers
Lack of GMP/cGMP knowledge, No experience with TPM or TPM sites, Inability to manage cross-functional teams
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