Senior/Principal Manufacturing Compliance Specialist
Core
Establish and sustain operational baseline for high-volume drug product manufacturing (compounding, filling, inspection) at a new state-of-the-art facility, ensuring regulatory compliance and quality.
Role type
Senior/Principal Manufacturing Compliance Specialist (Process & Compliance)
Builds
High-volume, highly-efficient Drug Product manufacturing operations
Domain
Pharmaceutical manufacturing (cGMP)
Required skills
cGMP knowledge, deviation management, change control management, root cause analysis, technical writing, regulatory inspection support, process validation exposure
Preferred skills
tech transfers, process validation, regulatory inspections
Technologies
MES, QMS/QDocs (Veeva)
Responsibilities
Author and approve cGMP documentation (SOPs, work instructions, batch records); manage deviations and change controls; support regulatory inspections; mentor team members; lead cross-functional issue resolution
Seniority
Senior (2-4 years exp) or Principal (5-7 years exp)