Proclinical is seeking an experienced Associate Director for a role in overseeing Quality Control Stability. The successful candidate will be responsible for setting up and overseeing a compliant stability program. This role involves leading stability studies, driving continuous improvement and supporting compliant testing applications for marketing approval and commercial supply.

Responsibilities:

Lead and oversee the QC Stability team. Manage the compliant stability program, including sample management, stability studies, and trending activities. 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. Plan capacity for the QC Stability group to ensure resource availability. Oversee the QC Stability team, including performance management and personnel development.

Key Skills and 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.