Position: Manager/Senior Manager/Associated Director of CMC QA

Level dependent on experience

Essential Duties and Responsibilities

Support the development, implementation, and improvement of company quality systems
Promote a culture of quality throughout the company and, increase compliance awareness with a focus on laboratory and manufacturing operations
Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
Write, review and revise standard operating procedures
Review, revise and approve validation protocols
Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
Review and approve manufacturing-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
Write inspection reports and prepare QA statements
Review and approve Certificates of Analysis and/or Certificates of Test
Perform internal and external audits of suppliers; assist in the resolution of non-conformances, deviations and investigations
Track open observations and Corrective and Preventative Actions (CAPA) to closure
Assist with the analysis of trends and metrics to ensure continuous quality improvements
Travel up to 20%
Other duties as assigned

Experience/Educational Qualifications

B.S. degree in a scientific discipline and at least three (3) years’ QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company
In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
Great attention to detail
Strong interpersonal skills
Strong prioritization, organizational and negotiating skills
Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
Solid time management skills and ability to handle multiple tasks and deliver high-quality results within set timelines

Supervisory Responsibilities

Please send CV and Cover Letter to hr@cellics.com to apply.