About this role
Associate Director, Quality provides leadership for AbbVie Quality Systems across operations, ensuring regulatory compliance and high-quality product delivery; manages budgets and leads a team of quality professionals across manufacturing facilities.
Key Responsibilities
- Responsible for QA/QC across plant operations
- Decision-making authority on quality/regulatory programs
- Manages quality team
- Provides regulatory guidance to departments
- Develops and administers annual Quality Unit budget
Technical Overview
Deep expertise in cGMP, FDA/EU/DEA regulations, EDMS/LIMS, quality planning and CAPA, with the ability to guide regulatory and technical decisions and oversee quality metrics and audits.
Ideal Candidate
The ideal candidate is a senior quality leader with 15+ years in pharma QA/QC, capable of steering large, cross-functional quality programs across manufacturing sites. They possess strong regulatory knowledge (FDA/EU/DEA), budget oversight, and mentor teams to ensure rigorous cGMP compliance.
Must-Have Skills
Bachelor's Degree15+ years of combined experience in ManufacturingQAQCR&D in pharmaceuticalbiologicsdevice or chemical industry10+ years of supervisory/technical leadership experienceBasic understanding and working knowledge of the physical and chemical characteristics of productsFamiliar with statistical quality systemsEDMS and LIMSFamiliar with Quality policies and cGMP and other regulatory requirementsStrong people management and communication skills
Nice-to-Have Skills
Certified Quality Engineer or formal training in quality engineering or statisticsMaster's or PhD preferred
Required Skills
Bachelor's degree in Physical or Life SciencesPharmacyor Engineering; 15+ years of combined experience in ManufacturingQAQCR&D in pharmaceuticalbiologicsdevice or chemical industry; 10+ years supervisory/technical leadership; basic understanding of product characteristics; familiarity with statistical quality systemsEDMSLIMS; knowledge of cGMP and regulatory requirements; strong communication and leadership
Hard Skills
Quality SystemscGMPFDA regulatory complianceRegulatory ComplianceQuality AssuranceQuality ControlValidationStatistical quality systemsElectronic Document Management (EDMS)Laboratory Information Management (LIMS)Budget managementPeople managementRegulatory guidanceQuality planningCAPAQuality metricsProcess improvementSOP
Soft Skills
Strong communicationLeadershipTeam managementCross-functional collaborationStakeholder management
Certifications
Preferred
Certified Quality Engineer (CQE)
Keywords for Your Resume
Associate DirectorQualityQuality SystemscGMPFDAEUDEARegulatory ComplianceQuality AssuranceQuality ControlValidationEDMSLIMSBudget managementPeople managementRegulatory guidanceProcess improvementCAPASOPRegulatory submissionsCQEQuality Engineer
Deal Breakers
Bachelor's degree missing, Less than 15 years pharma QA/R&D experience, No supervisory/leadership experience, Lack of familiarity with EDMS or LIMS, No knowledge of cGMP or regulatory requirements
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