Regulatory Compliance Manager
Core
Ensure Quality Management System (QMS) compliance with global regulations for aseptic manufacturing and sterile filling operations.
Role type
Senior Regulatory Compliance Manager
Builds
Inspection-ready quality systems for healthcare authorities and customers
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Required skills
cGMP, FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH guidelines, Auditing, Root cause analysis, Data Integrity (ALCOA+), Cleanroom classifications, Contamination Control Strategy, Process Validation, Internal Audit, eQMS systems
Preferred skills
None stated
Technologies
eQMS systems
Responsibilities
Ensure compliance with cGMP and global regulatory requirements; Maintain inspection readiness for healthcare authorities; Lead regulatory inspections and customer audits; Coordinate responses to audit observations; Monitor changes in global regulations; Develop and execute internal audit schedules; Analyze quality system trends; Recommend process improvements; Provide compliance oversight for aseptic processing; Ensure compliance with contamination control strategies; Participate in investigations using root cause analysis; Develop cGMP training programs; Mentor departments on regulatory expectations.
Seniority
Senior, hands-on IC