Senior Manager, QA Documentation
Core
Ensure compliance with regulatory guidelines and standard operating procedures for QA functions in pharmaceutical manufacturing.
Role type
Senior Manager, Quality Assurance
Builds
Finished pharmaceutical products (oncology focus)
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Required skills
Regulatory compliance, Batch record review, Validation management, Change control, Deviation handling, CAPA, Risk assessment, Audit leadership, Complaint handling, Recall management, SOP development
Preferred skills
Oncology product knowledge, cGMP expertise, Strategic quality governance
Responsibilities
Lead and facilitate audit and compliance at site; Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR); Oversee validation activities including Qualification and Requalification protocols; Manage product complaints and recalls; Ensure environmental monitoring trends; Lead management review of process performance and quality management system.
