Assistant Director, Quality Assurance, Control
Emory University
full-time
Posted on:
Location Type: Office
Location: Atlanta • United States
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Job Level
About the role
- Overseeing the implementation, maintenance, and improvement of quality systems to ensure products meet regulatory requirements and established standards.
- Acts as a key decision-maker, manages a team of quality professionals, and ensures compliance with Current Good Manufacturing Practices (cGMPs).
- Support the implementation, development, and maintenance of the QMS to comply with regulations from agencies like the FDA, EMA, and ICH.
- Oversee the creation, approval, and review of batch records, analytical data, and supporting documentation.
- Lead or support investigations into deviations, out-of-specification/trend (OOS/OOT) results, and laboratory incidents.
- Coordinate internal audits, host external regulatory inspections, and manage responses to audit findings.
- Ensure proper control and review of Good Manufacturing Practices (GMP) documentation.
- Support the qualification, periodic review, and auditing of contract manufacturing organizations (CMOs) and other GMP vendors.
- Monitor key performance indicators (KPIs) and quality metrics to identify trends and lead quality improvement initiatives.
- Manage and mentor a team of quality professionals, setting goals, monitoring performance, and fostering a strong quality culture.
- Serve as a quality liaison, collaborating with cross-functional teams to ensure quality integration across workflows.
Requirements
- Bachelor's degree in Microbiology, Chemistry, Biology or a related scientific field
- five years of experience in a GMP-regulated environment producing related products or an equivalent combination of education and experience.
- GMP quality and previous supervisory experience.
Benefits
- Health and safety Information
- Working in a laboratory
- Working with human blood, body fluids, tissues, or other potentially infectious materials
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality systemsCurrent Good Manufacturing Practices (cGMP)Quality Management System (QMS)batch recordsanalytical datadeviationsout-of-specification results (OOS)out-of-trend results (OOT)internal auditskey performance indicators (KPIs)
Soft Skills
decision-makingteam managementmentoringgoal settingperformance monitoringcollaborationcommunicationleadershiporganizational skillsquality culture
Certifications
Bachelor's degree in MicrobiologyBachelor's degree in ChemistryBachelor's degree in Biology