Job Overview
Proclinical is seeking an experienced Associate Director to oversee Quality Control Stability in a compliant program. The successful candidate will be responsible for setting up and overseeing a compliant stability program, leading stability studies, driving continuous improvement, and supporting compliant testing applications for marketing approval and commercial supply.
Key Responsibilities:
* Manage the compliant stability program, including sample management, stability studies, and trending activities.
* Lead and oversee the QC Stability team.
* Write and review SOPs, summary, and trend reports.
* Establish and maintain procedures for a compliant stability program.
* Manage stability chambers setup and equipment validation.
* Lead complex investigations into OOS or OOT results with cross-functional experts.
* Troubleshoot assays and implement solutions to drive continuous improvement.
* Oversee external vendors/contract testing facilities for QC Stability testing needs.
* Create and support execution of stability programs for products.
* Review and complete documentation in accordance with cGMP.
* Handle change control and deviations related to QC Stability.
* Author QC regulatory documentation and assist in regulatory audits/inspections.
* Develop and maintain a culture of continuous improvement within the QC team.
Requirements:
* Degree in Chemistry, Biochemistry, Microbiology, or related science.
* Experience in GLP/GMP environments and laboratory-based testing.
* Management experience in a GMP-regulated environment.
* Strong analytical skills and technical experience in product/raw materials testing.
* Knowledge of statistical packages such as JMP.
* Proficiency in MS Word and Excel.
* Effective communication and organizational skills.
* Ability to work well as a team.