Manager, Analytical Quality Assurance
Core
Provide QA review and approval of technical documents and Quality Management System (QMS) records for Commercial GMP analytical methods for biologics and small molecules drug substances and drug products.
Role type
Manager, Quality Assurance (Pharmaceuticals)
Builds
Commercial method validation, transfer, and lifecycle documentation for biologics and small molecules
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Required skills
GMP documentation review, analytical method validation, change control management, CAPA resolution, electronic QMS proficiency, FDA guidelines knowledge, GxP regulations
Preferred skills
Biologics and/or Small Molecule QA/QC experience, analytical chemistry, method development
Technologies
DCA, Veeva, PDLIMS, Trackwise
Responsibilities
Review and approve GMP documentation including analytical method validation and transfer, procedures, protocols, reports, and CoAs; Collaborate on resolutions for protocol deviations and exceptional conditions; Perform Quality approval of QMS records including change controls and effectiveness checks; Assist in continuous improvement initiatives for Quality and QC functions
Seniority
Manager, hands-on leadership