Director, Quality Control

MS or PhD degree in Chemistry, Biology, Biochemistry, or related field 10+ years of related experience 7+ years in Quality Control management for director level within the biotech or pharmaceutical industry Strong quality compliance and collaborative mindset Strong knowledge of cGMP, FDA, EMA, and ICH regulations Strong experience in analytical method development including phase appropriate method qualification, transfer and validations Experience with common analytical techniques such as common compendial methods, HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development Proven leadership in managing internal QC operations or external CDMOs Excellent communication, organizational, and problem-solving skills

Develop and implement QC strategies with internal and external partners Oversee batch release and stability testing, method development, qualification, transfer and validation at CDMOs Develop product specifications and oversee testing strategy and execution Create and manage QC documentation Collaborate with other CMC functions, QA and Regulatory to support tech transfers and lifecycle management Manage CDMO relationships Review and approve CDMO generated data, investigations, and documentation Ensure timely investigation and resolution of OOS results, deviations, and CAPAs Serve as QC subject matter expert during regulatory inspections and audits