Senior Associate Quality Systems (CCS)
Core
Lead the cross-company Contamination Control Strategy (CCS) quality system as a subject matter expert, including training, assessment, and continuous improvement.
Role type
Senior Associate Quality Systems (CCS) SME
Builds
QM systems, SOPs, and specification documents for CCS, qualification, validation, document management, and risk management
Domain
Biopharmaceutical manufacturing and quality assurance
Required skills
Contamination Control Strategy (CCS) expertise, GMP process knowledge, regulatory specialist knowledge, project leadership, SOP design, risk management
Preferred skills
PhD, Contamination Control Strategy (CCS) experience
Technologies
GMP, SOPs, validation tools, document management systems
Responsibilities
Lead cross-company CCS quality system, design QM systems and create SOPs, consult on critical events, train employees on GMP processes, initiate quality improvement initiatives, represent QM systems to customers and authorities
Seniority
Senior, hands-on IC
