Emory University · 2 days ago
Assistant Director, Quality Assurance & Control- Winship Cancer Institute
Atlanta, GA, US
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expEmory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is seeking an Assistant Director of Quality Assurance & Control to oversee quality systems ensuring compliance with regulatory requirements and established standards. The role involves managing a team, supporting quality management systems, and leading continuous improvement initiatives.
EducationE-LearningHealth Care
Responsibilities
Assistant Director of Quality Assurance/Quality Control (QA/QC) is responsible for 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)
Quality Management System (QMS) Oversight: Support the implementation, development, and maintenance of the QMS to comply with regulations from agencies like the FDA, EMA, and ICH
Batch Review and Product Release: Oversee the creation, approval, and review of batch records, analytical data, and supporting documentation to ensure timely disposition of materials, intermediates, and finished products.Generates Certificates of Analysis for all facility produced drug products
Deviation and Investigation Management: Lead or support investigations into deviations, out-of-specification/trend (OOS/OOT) results, and laboratory incidents, ensuring thorough root cause analysis and effective Corrective and Preventive Actions (CAPAs) are implemented
Audits and Inspections: Coordinate internal audits, host external regulatory inspections, and manage responses to audit findings with effective corrective actions
Documentation and Training: Ensure proper control and review of Good Manufacturing Practices (GMP) documentation, including authoring, reviewing, and approving Standard Operating Procedures (SOPs), quality policies, and training materials
Vendor and Site Oversight: Support the qualification, periodic review, and auditing of contract manufacturing organizations (CMOs) and other GMP vendors, addressing performance and compliance issues
Continuous Improvement: Monitor key performance indicators (KPIs) and quality metrics to identify trends and lead quality improvement initiatives that enhance compliance, efficiency, and product quality
Leadership and Mentorship: Manage and mentor a team of quality professionals, setting goals, monitoring performance, and fostering a strong quality culture within the organization
Collaboration: Serve as a quality liaison, collaborating with cross-functional teams such as Manufacturing, Product Development, Operations, and Regulatory Affairs to ensure quality integration across workflows and adherence to cGMP requirements
Performs related responsibilities as required
Qualification
Required
Bachelor's degree in Microbiology, Chemistry, Biology or a related scientific field
Five years of experience in a GMP-regulated environment producing related products
Equivalent combination of education and experience
Preferred
GMP quality experience
Previous supervisory experience
Company
Emory University
Emory University is an institute of higher learning and a private research university.
10001+ employees
H1B Sponsorship
Emory University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (417)
2024 (370)
2023 (308)
2022 (266)
2021 (164)
2020 (162)
Funding
Current Stage
Late StageTotal Funding
$719.87MKey Investors
GettyNational Institutes of HealthHyundai Hope On Wheels
2025-08-20Grant· $0.28M
2024-11-13Grant· $15M
2024-08-28Grant· $0.4M
Leadership Team
Claire E Sterk
President Emerita and Charles Howard Candler Professor of Public Health
Gregory Fenves
Chancellor
Recent News
2026-01-16
News-Medical.Net
2025-11-23
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