Global QC Product Lead
Core
Strategic Quality leadership and governance for the implementation and lifecycle management of commercial analytical methods across AbbVie's global QC network.
Role type
Senior, hands-on IC Global QC Product Lead
Builds
Commercial analytical methods, validation strategies, and method transfer plans for late-stage and commercial products
Domain
Pharmaceutical Quality Control / Analytical Chemistry
Required skills
Analytical lifecycle expertise, GMP knowledge, Data integrity principles, Risk-based decision making, Cross-functional leadership, Method validation and transfer, Laboratory capability assessment, Regulatory compliance, Stakeholder management, Technical mentoring
Preferred skills
Experience with multiple analytical technologies, Regulatory submission support, Platform approach establishment, Global standards development
Technologies
HPLC, GC, Mass Spectrometry, Bioassays, Chromatography, Spectroscopy, Cell-based assays
Responsibilities
Lead global QC analytical implementation and lifecycle strategy; Represent Global QC in cross-functional product and CMC discussions; Translate development strategies into robust QC execution approaches; Independently review and approve validation and method transfer strategies; Determine final QC method design balancing scientific and regulatory needs; Assess receiving-site readiness and mitigate implementation barriers; Lead alignment across R&D, PDS&T, Operations Quality, and Regulatory Affairs; Provide scientific leadership for complex method transfer challenges and troubleshooting; Identify and communicate scientific, regulatory, and operational risks; Drive harmonization and best practices across the global QC network; Mentor QC scientists and communicate complex technical matters to leadership.
Seniority
Principal, strategy & mentorship