Supervisor, Quality Assurance
Core
Lead the Quality Assurance function to ensure compliance with Quality Systems, Finished Product Batch Release, and Change Control in a large-scale oral solid dose manufacturing facility.
Role type
Senior IC Quality Assurance Supervisor
Builds
Pharmaceutical oral solid dose products (tablets, capsules) for pharma and consumer health programs
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Quality Systems compliance, Batch review, cGMP, Root cause analysis, CAPA management, SOP authoring, Regulatory inspection support, Team supervision, HR policy implementation, Quality software proficiency (TrackWise, Documentum)
Preferred skills
Prior supervisory experience (5+ reports), Life Science degree, Technical writing for investigations
Technologies
TrackWise, Documentum, Microsoft Office Suite
Responsibilities
Ensure Quality systems comply with corporate procedures and industry standards; Supervise Quality Assurance Associates; Participate in FDA inspections and customer audits; Author and maintain Standard Operating Procedures; Facilitate Investigations, Complaints, and Annual Product Reviews; Manage CAPA commitments and trending; Recommend process changes based on quality trends; Serve as liaison to other departments and regulators; Maintain employee performance documentation and administer discipline.
Seniority
Senior, hands-on IC with leadership responsibilities
