Assistant Director, Quality Assurance & Control- Winship Cancer Institute
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Job Location:
Atlanta, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Discover Your Career at Emory University
Description
About Winship Cancer Institute of Emory University
Dedicated to discovering cures for cancer and inspiring hope Winship Cancer Institute of Emory University is Georgias 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 patients 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 is Where Science Becomes Hope. For more information visit .
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).
- 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 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.
MINIMUM QUALIFICATIONS:
- Bachelors 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.
PREFERRED QUALIFICATIONS:
- GMP quality and previous supervisory experience.
Additional Details
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation please contact the Department of Accessibility Services at or call (Voice) (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
"Have a Coke and a smile" means more to Emory University than it does to the rest of the world. The school, which has some 13,300 students and about 12,500 staff and faculty members, has a very low student-teacher ratio of about 7:1. It changed from Emory College to Emory University i ... View more
