Assistant Director, Quality Assurance & Control- Winship Cancer Institute
About The Position
Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient’s needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu. Winship is seeking qualified candidates for the Assistant Director, Quality Assurance & Control position. Position details are as follows: JOB DESCRIPTION: 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).
Requirements
- Bachelor's degree in Microbiology, Chemistry, Biology or a related scientific field and five years of experience in a GMP-regulated environment producing related products or an equivalent combination of education and experience.
Nice To Haves
- GMP quality and previous supervisory experience.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
