Sr cGMP Pharmaceutical Manager
Core
Overseeing and supporting quality assurance responsibilities at pharmaceutical/drug manufacturing sites to ensure full compliance with cGMP regulations and ICH guidelines.
Role type
Senior IC Quality Manager (cGMP Pharmaceutical)
Builds
Compliant pharmaceutical/drug product supply
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Deliverable
client delivery
Required skills
cGMP knowledge and application, FDA inspection management, CAPA management, validation expertise, supplier quality oversight, Management Review leadership, deviation and OOS analysis, change control management, statistical process control (SPC), quality risk management (ICH Q9), data integrity knowledge (21 CFR Part 11), eQMS platform proficiency
Preferred skills
Contract manufacturing organization (CMO) oversight, EU GMP Annex requirements knowledge, process capability analysis, advanced technical degree
Technologies
SAP, QMS, qTrack, Agile
Responsibilities
Lead and demonstrate cGMP knowledge and training; Actively participate in FDA inspections and regulatory audits; Assess effectiveness of pharma requirements at sites; Perform analysis of deviations, OOS results, complaints, and audit findings; Escalate critical quality issues to senior leadership; Provide inputs into Management Reviews; Manage the change control program; Serve as quality representative during regulatory inspections; Prepare site and personnel for regulatory inspections and manage responses to FDA observations.
Seniority
Senior, hands-on IC with direct people management