Senior Manager, Quality Control, Reference Standards

Ph.D. with 5+ years of relevant QC experience, or MS with 7+ years, or BS with 9+ years, including reference standard management. Strong background in cGMP and ICH regulatory guidance. Experience with biochemistry, immunoassay, or microbiological assay techniques. Familiarity with statistical software (e.g., JMP). Excellent organizational and project management skills. Strong written and verbal communication skills. Proficiency in LIMS and other laboratory data management systems is preferred.

Oversee reference standards and critical reagent program management and continuous supply. Support development of global business practices, policies, and standards. Collaborate in authoring and reviewing technical protocols, qualification reports, and CoAs. Manage supply chain logistics for inventory and space planning. Serve as a key point of contact for internal and external partners. Provide technical guidance on assay qualification and validation. Review and manage deviations, OOS/OOT results, and conduct risk assessments.