Regulatory Compliance Manager
Core
Ensures Quality Management System (QMS) compliance with global regulations for aseptic manufacturing and sterile filling operations, leading inspection readiness and continuous improvement.
Role type
Senior IC Regulatory Compliance Manager (Pharmaceutical)
Builds
Inspection-ready quality systems for sterile pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, FDA 21 CFR Parts 210/211 expertise, EU GMP Annex 1 knowledge, ICH guidelines (Q7, Q8, Q9, Q10), auditing, root cause analysis (CAPA), Data Integrity (ALCOA+), cleanroom classifications, Contamination Control Strategy, process/cleaning validation, media fill programs, QMS management
Preferred skills
eQMS systems experience, digital quality initiatives, risk-based decision making
Technologies
eQMS systems, FDA Form 483, ISO 14644
Responsibilities
Lead regulatory inspections and customer audits, coordinate responses to audit observations, develop and execute internal audit schedules, monitor global regulation changes, provide compliance oversight for aseptic processing, develop cGMP training programs, mentor departments on regulatory expectations
Seniority
Senior, hands-on IC