Quality/Regulatory Supervisor
Core
Ensures quality products are manufactured in alignment with national, regional, and global regulations and company policies.
Role type
Quality/Regulatory Supervisor
Builds
Safe, compliant pharmaceutical products for customers
Domain
Pharmaceutical manufacturing
Required skills
CGMP regulations, ICH guidelines, CFR requirements, quality systems, batch record review, CAPAs, change controls, leadership, coaching
Preferred skills
SAP, LIMS, BM/RAM, electronic document management systems, audit support, batch disposition, regulatory inspections
Technologies
SAP, LIMS, BM/RAM
Responsibilities
Develops and implements quality programs and systems; provides quality oversight for Manufacturing and Materials Management; leads batch record review and documentation activities; acts as a change agent for continuous improvement; manages documentation generation and retention; supports audits and inspections; resolves quality issues and implements CAPAs; supervises Manufacturing Quality Engineers; supports 24/7 operations including off-shift activities.
Seniority
Supervisor, hands-on leadership
