Senior Specialist Quality Assurance
Core
End-to-end Quality Assurance oversight for a new biologics manufacturing campus, ensuring compliance, data integrity, and batch release across small molecule, large molecule, conjugation, and fill-and-finish operations.
Role type
Senior Specialist Quality Assurance (Manufacturing)
Builds
End-to-end Antibody-Drug Conjugate (ADC) manufacturing capabilities with digital and automation infrastructure.
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
cGMP compliance, Pharmaceutical Quality Systems, deviation management, CAPA, validation, change control, risk assessment, supplier quality oversight, data analysis, regulatory inspection readiness
Preferred skills
New product introduction support, technology/analytical transfers, digital pharmaceutical systems, AI-enabled transformation, process improvement methodologies (Lean, Six Sigma)
Technologies
Digital pharmaceutical systems, data visualization platforms, analytics solutions
Responsibilities
Guide execution of core quality processes and ensure data integrity; Provide direct daily QA oversight in manufacturing suites and labs; Review and approve investigations, root causes, and CAPAs; Approve qualification, validation results, and product releases; Advise on GxP expectations and coordinate regulatory inspections; Support supplier quality management; Analyze quality metrics using digital tools; Lead complaint investigations and corrective actions; Coach team members on processes and compliance
Seniority
Senior, hands-on IC
